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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
Results First Submitted: January 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Spinal Cord Injury
Interventions: Behavioral: Endurance
Behavioral: Precision

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Endurance First Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for 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.
Precision First Participants 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 is 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 is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.

Participant Flow for 4 periods

Period 1:   Training Phase 1
    Endurance First   Precision First
STARTED   10   11 
COMPLETED   9   10 
NOT COMPLETED   1   1 
Format of intervention differed                1                0 
Poor participation in intervention                0                1 

Period 2:   Rest Phase 1
    Endurance First   Precision First
STARTED   9   10 
COMPLETED   9   9 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 3:   Training Phase 2
    Endurance First   Precision First
STARTED   10 [1]   9 
COMPLETED   10   8 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 
[1] 1st subject didn't use same training(phase 1) as subsequent participants Phase 1 and 2 data removed.

Period 4:   Rest Phase 2
    Endurance First   Precision First
STARTED   10   8 
COMPLETED   8   7 
NOT COMPLETED   2   1 
Lost to Follow-up                2                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Endurance First Participants 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 is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 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.
Precision First Participants 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 is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
Total Total of all reporting groups

Baseline Measures
   Endurance First   Precision First   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.1  (14.4)   44.0  (13.2)   45.9  (13.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  30.0%      4  36.4%      7  33.3% 
Male      7  70.0%      7  63.6%      14  66.7% 
Region of Enrollment 
[Units: Participants]
     
Canada   10   11   21 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

21.  Secondary:   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 ]

22.  Secondary:   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 ]

23.  Secondary:   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 ]

24.  Secondary:   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 ]

25.  Secondary:   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 ]

26.  Secondary:   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 ]

27.  Secondary:   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 ]

28.  Secondary:   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 ]

29.  Secondary:   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 ]

30.  Secondary:   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 ]

31.  Secondary:   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 ]

32.  Secondary:   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 ]

33.  Secondary:   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 ]

34.  Secondary:   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 ]

35.  Secondary:   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 ]

36.  Secondary:   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 ]

37.  Secondary:   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 ]

38.  Secondary:   Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I   [ Time Frame: Change from Baseline I to 2 months of Training Phase I ]

39.  Secondary:   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 ]

40.  Secondary:   Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II   [ Time Frame: Change from Baseline II to 2 months of Training Phase II ]

41.  Secondary:   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 ]

42.  Secondary:   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 ]

43.  Secondary:   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 ]

44.  Secondary:   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 ]

45.  Secondary:   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 ]

46.  Secondary:   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 ]

47.  Secondary:   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 ]

48.  Secondary:   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 ]

49.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • Participants were a sample of convenience, likely the most highly motivated due to the time commitment.
  • Sample size was small.
  • 4 participants were less than 1 year post injury and may have had spontaneous recovery.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jaynie Yang
Organization: University of Alberta
phone: 780-492-2894
e-mail: jaynie.yang@ualberta.ca


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