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Trial record 49 of 306 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Stepping Training Using External Feedback in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT03254797
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sugalya Amatachaya, Khon Kaen University

Brief Summary:

Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI?

Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Stepping training with feedback Other: Stepping training without feedback Not Applicable

Detailed Description:

To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).

To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stepping training with feedback

Subjects will be instructed to perform the stepping task with external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes.

They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Other: Stepping training with feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
Active Comparator: Stepping training without feedback

Subjects will be instructed to perform the stepping task without external feedback continuously until 20 minutes (excluding resting periods) but without fatigue. Then they continue a training program of overground walking for 10 minutes.

They have to be involved in a training program of their groups 5 times/week, for 4 weeks in total.

Other: Stepping training without feedback
Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.



Primary Outcome Measures :
  1. Change of walking speed using 10 meter walk test (10MWT) [ Time Frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program ]
    The test measures walking speed. Subjects will be instructed to walk at a prefer speed and fastest speed along a 10 meters walkway with or without walking device. The video recording will be captured over the 4 meters in the middle walkway in order to minimize acceleration and deceleration effects. Then the data will be converted to a walking speed using a formula; (v = (step length (m) × cadence (step/min))/60)


Secondary Outcome Measures :
  1. Change of walking stability using Timed up and go test [TUGT] [ Time Frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program ]
    The test was designed to measure mobility and dynamic balance control related to walking. Subjects will be instructed to stand up from a standard chair, walk at a fastest and safe speed for 3 meters, turn around a traffic cone, walk back and sit down on the chair with or without a walking device. Then the average time required for the 3 trials will be recorded.

  2. Change of lower limb muscle strength using Five times sit-to-stand [FTSST] [ Time Frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program ]
    The test has used to quantify lower extremity motor strength. The time taken to complete 5 chair-rise cycles at a fastest and safe speed will be recorded for each subject. Then the average time required for the 3 trials will be used for data analysis.

  3. Change of walking endurance using 6 minute walk test (6MWT) [ Time Frame: prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program ]
    The test measures the longest walking distance in 6 minute to reflect the responses of the cardiopulmonary and muscular systems. Subjects will be instructed to walk along a rectangular walkway as long as they can with a safety speed. They can walk with or without walking device in 6 minutes and are able to take a resting period as needed and continuing to walk. The distance covered after 6 minutes will be recorded.



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

Inclusion Criteria:

  • Independent ambulatory patients with iSCI
  • Non-traumatic or traumatic causes
  • Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
  • Age at least 18 years
  • Body mass index (BMI) between 18.5 - 29.9 kg/m2.

Exclusion Criteria:

  • Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as

    • Brain function disorders
    • Visual deficits that cannot be corrected using glasses or contact lens
    • Musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale)
    • Deformity of the musculoskeletal system
    • Unable to follow a command of the tests
    • Unstable medical conditions
    • Color blindness

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): NCT03254797


Contacts
Contact: Teerawat Nithiatthawanon +66-81-4972730 teerawanon@kkumail.com

Locations
Thailand
Faculty of Associated Medical Science Recruiting
Khon Kaen, Muang, Thailand, 40002
Contact: Teerawat Nithiatthawanon    +66-81-4972730    teerawanon@kkumail.com   
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Sugalya Amatachaya School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Publications:

Responsible Party: Sugalya Amatachaya, Assoc. Prof. Dr., Khon Kaen University
ClinicalTrials.gov Identifier: NCT03254797     History of Changes
Other Study ID Numbers: PHD/0194/2557
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sugalya Amatachaya, Khon Kaen University:
Rehabilitation
Neurological condition
Walking ability
Feedback
External information

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