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Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765153
First Posted: January 10, 2013
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta
  Purpose
The objective of the study was to determine the efficacy of two forms of physical therapy training, one emphasizing precise, visually guided walking over obstacles and on targets (Precision Training), the other emphasizing mass practice of walking on a treadmill (Endurance Training). The hypothesis was that visually guided training (Precision) may be especially efficacious because it engages the motor cortex, whose input may facilitate improvements in functional walking. Participants are individuals with a chronic (≥7 months post-injury), motor incomplete spinal cord injury (SCI), with no other problems that would preclude participation in an intensive training program. A randomized, single-blinded, cross-over design was used to randomly allocate participants to start with Precision or Endurance Training, identified as Training Phase I. Training was 5x/wk for 2 months, followed by a 2-month rest period, identified as Rest Period I. Participants then returned for 2-months of training in the other method, identified as Training Phase II, followed by another 2-month rest, Rest Period II. Measures of walking speed, distance, skill, confidence, as well as depression were obtained at least 3 times before any training, then monthly thereafter. Electrophysiological measures were taken before and after each phase of training and period of rest. Change scores were used to determine how each phase of training and rest influenced the scores (see below).

Condition Intervention
Spinal Cord Injury Behavioral: Endurance Behavioral: Precision

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Precision Versus Endurance Training to Improve Walking After Chronic Incomplete SCI

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study [ Time Frame: Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study) ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.


Secondary Outcome Measures:
  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.

  • Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.

  • Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Participants walk for as far as possible in 6 min along a 25m hallway.

  • Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.

  • Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.

  • Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training to 2 months of Rest Period II ]
    Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.

  • Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.

  • Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

    Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]

    Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]

    Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]

    Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

    Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]

    Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]

    Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]

    Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.

    Results are reported as Final score - Initial score. A positive result indicates that less assistance was required.


  • Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

    A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.

    Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.


  • Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]

    A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.

    Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.


  • Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]

    A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.

    Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.


  • Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]

    A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.

    Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability.


  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

    A 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.

    Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.


  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]

    A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.

    Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.


  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]

    A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.

    Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.


  • Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]

    A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.

    Results are reported as Final score - Initial score. A negative result indicates a lower level of depression.


  • Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

    The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).

    Results are reported as Final score - Initial score. A positive result indicates an increase in strength.


  • Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]

    The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).

    Results are reported as Final score - Initial score. A positive result indicates an increase in strength.


  • Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.

  • Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]

    The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).

    Results are reported as Final score - Initial score. A positive result indicates an increase in strength.


  • Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.

  • Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.

  • Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.

  • Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    Maximum evoked potentials were measured and compared to baseline measures for major muscle groups.

  • Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I [ Time Frame: Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.

  • Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II [ Time Frame: Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II ]
    Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.


Enrollment: 21
Study Start Date: March 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endurance first
Participants to start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.
Behavioral: Endurance
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
Other Names:
  • Treadmill walking training
  • Body-weight supported treadmill training
Behavioral: Precision
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
Other Name: Skill walking training
Experimental: Precision first
Participants to start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest. Measures of walking speed, distance, skill, confidence, as well as mood were obtained at least 3 times before any training, then monthly thereafter.
Behavioral: Endurance
Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
Other Names:
  • Treadmill walking training
  • Body-weight supported treadmill training
Behavioral: Precision
Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
Other Name: Skill walking training

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  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spinal cord injury equal or more than 7 months prior
  • able to walk at least 5 meters independently (can use walking aids and braces)
  • injury level between C1 and L1
  • able to give informed consent
  • able to attend training sessions 5x/week

Exclusion Criteria:

  • head injury
  • cognitive of musculoskeletal impairments that preclude participation in walking training
  • seizures or implants in the head that would preclude participation in experiments with transcranial magnetic stimulation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765153


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jaynie Yang, PhD University of Alberta
Principal Investigator: Monica Gorassini, PhD University of Alberta
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01765153     History of Changes
Other Study ID Numbers: Pro00003873
First Submitted: November 30, 2012
First Posted: January 10, 2013
Results First Submitted: January 16, 2017
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017
Last Verified: January 2017

Keywords provided by University of Alberta:
physical therapy
rehabilitation
neuroplasticity

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries