The effect of GRAIL training on functional walking capacity and social participation in patients with incomplete spinal cord injury.

Completed

Conditions: 10041543
incomplete spinal cord injury
partial paralysis

Registration Number: NL-OMON48297

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria
- SCI classification (American Spinal Injury Association Impairment Scale (AIS)
C or D))
- At least 6 months post injury-onset to ensure a stable neurological condition
- Able to walk at least 10m with or without a walking aid and/or braces
- Walking speed at inclusion between 0 3 and 1 0 m/s (measured with the 10MWT)
- A rehabilitation goal on improving (functional) walking capacity
- Age >18 years
- Willingness and ability to cancel/postpone other interventions or treatments
aimed at improving functional balance capacity or participation during the
study duration

Exclusion Criteria

The main exclusion criteria are
- Other neurological or lower limb impairments in addition to the iSCI
- Walking or balance problems prior to the iSCI
- Expected life events during the study period that influence the activity
level of the patient (such as retirement, parenthood, a new job or an operation)
- Within the first 6 months after a previous GRAIL trajectory
- Scheduled Botulinum Toxin (Botox) injections during the intervention period.
- Insufficient understanding or mastery of the Dutch language to understand
training and measurement instructions

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Walking speed measured with the 2 minutes walking test (2MWT).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Functional walking ability measured with the spinal cord injury - functional<br /><br>ambulation profile (SCI-FAP)<br /><br>3. Participation measured with the Utrecht scale for evaluation of<br /><br>rehabilitation-participation (USER-P).<br /><br>4. Two rehabilitation goals, one on the activity level and one on participation<br /><br>level of the ICF, assessed with the Goal Attainment Scaling (GAS)<br /><br>5. Walking speed measured with the 2 minute walking test (2MWT) during<br /><br>self-paced treadmill walking on the GRAIL.<br /><br>6. Balance confidence measured with the activities-specific balance confidence<br /><br>(ABC) scale<br /><br>7. Patients* experience on the different interventions will be captured with a<br /><br>customized questionnaire.</p><br>