Immediate Effects of Stepping Training With or Without External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Khon Kaen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change of walking balance using Timed up and go test [TUGT]
Study Overview
Brief Summary
- Does stepping training with or without external feedback change functional ability of ambulatory patients with iSCI immediately after training?
- Are there significant differences between the immediate effects of stepping training with or without external feedback in ambulatory patients with iSCI?
Detailed Description
To compare immediate effects of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (between-group comparison).
Secondary objective To compare immediate effects in a group of stepping training with or without the utility of external feedback on functional ability relating to walking in ambulatory patients with iSCI (within-group comparison).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Independent ambulatory patients with iSCI at a chronic stage (Post-injury time > 12 months)
- •Traumatic cause or non-progressive disease
- •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
Arms & Interventions
A to B
Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).
Intervention: Stepping training without feedback (Other)
A to B
Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B).
Intervention: Stepping training with feedback (Other)
B to A
Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).
Intervention: Stepping training with feedback (Other)
B to A
Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A).
Intervention: Stepping training without feedback (Other)
Outcomes
Primary Outcomes
Change of walking balance using Timed up and go test [TUGT]
Time Frame: Baseline and immediately after complete one section 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 Outcomes
- Change of walking speed using 10 meter walk test (10MWT)(Baseline and immediately after complete one section training program)
- Change of lower limb muscle strength using Five times sit-to-stand [FTSST](Baseline and immediately after complete one section training program)
- Change of lower limb support ability [LLSA] on more and less affected legs(Baseline and immediately after complete one section training program)
Investigators
Sugalya Amatachaya
Assoc. Prof. Dr.
Khon Kaen University