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Stepping Training Using External Feedback in Spinal Cord Injury Patients

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Stepping training with feedback

Stepping training without feedback

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Rehabilitation, Neurological condition, Walking ability, Feedback, External information

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Associated Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepping training with feedback

Stepping training without feedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of walking stability using Timed up and go test [TUGT]

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.

Secondary Outcome Measures

Change of walking speed using 10 meter walk test (10MWT)

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)

Change of lower limb muscle strength using Five times sit-to-stand [FTSST]

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.

Change of walking endurance using 6 minute walk test (6MWT)

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.

Full Information

NCT ID

NCT03254797

First Posted

August 15, 2017

Last Updated

June 12, 2020

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT03254797

Brief Title

Stepping Training Using External Feedback in Spinal Cord Injury Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

August 20, 2017 (Actual)

Primary Completion Date

September 20, 2019 (Actual)

Study Completion Date

March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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?

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

Rehabilitation, Neurological condition, Walking ability, Feedback, External information

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stepping training with feedback

Arm Type

Experimental

Arm Description

Arm Title

Stepping training without feedback

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Stepping training with feedback

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Stepping training without feedback

Intervention Description

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 Measure Information:

Title

Change of walking stability using Timed up and go test [TUGT]

Description

Time Frame

prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Secondary Outcome Measure Information:

Title

Change of walking speed using 10 meter walk test (10MWT)

Description

Time Frame

prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Title

Change of lower limb muscle strength using Five times sit-to-stand [FTSST]

Description

Time Frame

prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

Title

Change of walking endurance using 6 minute walk test (6MWT)

Description

Time Frame

prior to training, after 2 weeks, after 4 weeks, and 6 months after complete the training program

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sugalya Amatachaya

Organizational Affiliation

School of Physical Therapy, Khon Kaen University, Thailand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Associated Medical Science

City

Khon Kaen

State/Province

Muang

ZIP/Postal Code

40002

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

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Stepping Training Using External Feedback in Spinal Cord Injury Patients

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