Immediate Effects of Stepping Training Using External Feedback in Spinal Cord Injury Patients

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).

Official Title
-----------------
Immediate Effects of Stepping Training With or Without External Feedback on Walking and Functional Ability in Ambulatory Patients With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Other: Stepping training without feedback
* Other: Stepping training with feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A to B<br>Subjects were involved in an control training program (A). After 2 weeks washout period, Subjects were trained using the other program (B). | Other: Stepping training without feedback<br>* 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.<br>* Other names: Control program;Other: Stepping training with feedback<br>* 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.<br>* Other names: Experimental program;|
| Other: B to A<br>Subjects were involved in an control training program (B). After 2 weeks washout period, Subjects were trained using the other program (A). | Other: Stepping training without feedback<br>* 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.<br>* Other names: Control program;Other: Stepping training with feedback<br>* 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.<br>* Other names: Experimental program;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of walking balance 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. | Baseline and immediately after complete one section training program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of walking speed using 10 meter walk test (10MWT) | The test assessed the time required over the 4 m in the middle of the 10-m walkway at a comfortable and fastest speed with or without an assistive device. The time was converted to a walking speed using the formula: velocity (m/s) = distance (m)/ time (second). | Baseline and immediately after complete one section training program | 
| 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. | Baseline and immediately after complete one section training program | 
| Change of lower limb support ability [LLSA] on more and less affected legs | The test was assessed to reflect a risk of musculoskeletal disorders. Participants stood upright with placing the tested leg on the digital load cell (Model L6E3-C, accuracy up to 0.1 kg, and uncertainty of the measurement ± 0.082 kg: patent application number 1701004050) and the other leg posterolaterally to the tested leg. Participants were instructed to shift their body-weight anterolaterally onto the tested leg as much as they could, and step the other leg forward, with or without using the arms according to their ability. Then the LLSA data was reported in term of percent of the participant's body-weight. These data were presented for the less and more affected limbs as identified using the sensorimotor scores. Each participant performed five trials per leg, the first two trials served as practice trials, and an other three trials were used for data analysis. | Baseline and immediately after complete one section training program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Neurological condition, Walking ability, Feedback, External information