Stepping Training Using External Feedback in Spinal Cord Injury Patients

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Other: Stepping training with feedback; Other: Stepping training without feedback

• Registration Number: NCT03254797
• Lead Sponsor: 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?

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 Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-18
• Study Start: 2017-08-20
• Study First Posted: 2017-08-21
• Primary Completion: 2019-09-20
• Study Completion: 2020-03-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-12
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepping training with feedback	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.
Stepping training without feedback	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.

Primary Outcome Measures

Name	Time	Method
Change of walking stability using Timed up and go test [TUGT]	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.

Secondary Outcome Measures

Name	Time	Method
Change of walking speed using 10 meter walk test (10MWT)	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)
Change of walking endurance using 6 minute walk test (6MWT)	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.
Change of lower limb muscle strength using Five times sit-to-stand [FTSST]	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.

Trial Locations

Locations (1)

Faculty of Associated Medical Science; 🇹🇭 Khon Kaen, Muang, Thailand