Stepping Training Using External Feedback in Spinal Cord Injury Patients

June 12, 2020 updated by: Sugalya Amatachaya, Khon Kaen University

Effects of Stepping Training With External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Muang
      • Khon Kaen, Muang, Thailand, 40002
        • Faculty of Associated Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 = s/t)
prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
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.
prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program
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.
prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Sugalya Amatachaya, School of Physical Therapy, Khon Kaen University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2017

Primary Completion (ACTUAL)

September 20, 2019

Study Completion (ACTUAL)

March 20, 2020

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (ACTUAL)

August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHD/0194/2557

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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