Stepping Training Using External Feedback in Spinal Cord Injury Patients

Not Applicable

Completed

• Conditions: Spinal Cord Injuries

• 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

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