Innovative training method in patients with Multiple Sclerosis and Spinal Cord Injury, a pilot study.

Completed

Conditions: incomplete dwarslaesies
Multiple Sclerosis (MS)
Spinal Cord Injury (SCI)
10012303

Registration Number: NL-OMON46786

Lead Sponsor: ibra Revalidatie & Audiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Multiple Sclerosis (MS)
-EDSS * 6.5 (needs mainly support on two sides or support tools to walk 20 meters (EDSS <= 6.5), or performs better physically);
-Age * 18 years;;Spinal Cord Injury (SCI)
-WISCI-II score * 1 (ambulates in parallel bars, with braces and physical assistance of two persons, less than 10 meters (WISCI-II <= 1), or performs better physically);
-Age * 18 years;

Exclusion Criteria

- Contra-indications to perform a progressive cardiopulmonary exercise test (CPET) (Lausanne protocol );
- Abnormalities detected during the CPET which contra-indicate high intensity physical activities;
- Pregnancy;
- Unable to complete the full intervention based on time investment;
- Essential changes in medication during the intervention period (e.g. disease-modifying drugs in MS);
- Use of beta-blockers;
- MS Relapse during the intervention period;
- Malignant tumor as cause of SCI;
- Any premorbid (before diagnosis of MS/SCI) progressive neuromuscular or brain disease.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters: Primary parameters are:<br /><br>- aerobic capacity (progressive cardiopulmonary exercise test)<br /><br>- physical performance (Stair Climb Test, Progressive Isoinertial Lifting<br /><br>Evaluation, Sit To Stand test, Timed-up-and-Go test, 6 minute walk test maximal<br /><br>distance). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are:<br /><br>- maximal muscle strength (1RM handgrip, 1RM legpress),<br /><br>- walking efficiency (6 minute walk test at comfortable speed),<br /><br>- fatigue (Fatigue Severity Scale (FSS),<br /><br>- quality of life (Short Form (36) Health Survey (SF-36), and Multiple<br /><br>Sclerosis Impact Scale (MSIS-29)),<br /><br>- feasibility of the program (questionnaire developed for this study).<br /><br>*</p><br>