Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: Multiple Sclerosis research
| ISRCTN | ISRCTN60122826 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60122826 |
| Secondary identifying numbers | 050078 IWT TETRA |
- Submission date
- 19/08/2009
- Registration date
- 01/10/2009
- Last edited
- 01/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Bert Eijnde
Scientific
Scientific
Guffenslaan 39
Hasselt
B-3500
Belgium
Study information
| Study design | Single centre placebo-controlled clinical research trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: a single centre placebo-controlled Multiple Sclerosis research trial |
| Study acronym | MS rehabilitation |
| Study objectives | Regular and moderately intense rehabilitation of muscle strength improves functional capacity in multiple sclerosis (MS) patients. |
| Ethics approval(s) | Ethics Board of Hasselt University approved on the 24th October 2005 (ref: CME 2005/233) |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | Patients will be subjected to different rehabilitation modes during a period of 24 weeks and according to a specific treatment protocol: 1. Control 2. Strength training 3. Strength training and electro-stimulation 4. Whole body vibration 5. Micro-electrotherapy At baseline and following 12 and 24 weeks of therapy all endpoints will be measured. |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline, mid- (after 10 weeks intervention) and post-treatment (after 20 weeks of intervention): 1. Maximal isometric muscle strength of knee-extensors and flexors 2. Isotonic and isokinetic dynamic muscle strength using an isokinetic dynamometer 3. Functional performances 4. Blood samples 5. Motor control (surface electromyography [sEMG], in-phase and anti-phase motor coordination test equipment) 6. Quality of life (specific questionnaire) assessment |
| Secondary outcome measures | 1. Visual Analogue Scale (VAS) measured before and after each training session 2. Borg Scale measured after each training session |
| Overall study start date | 01/11/2005 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 patients subjected to four different rehabilitation modes |
| Key inclusion criteria | 1. MS patients (Expanded Standard Disbility Status Scale [EDSS] 0.5 - 3) that have functional muscle and motor functional disabilities 2. Males and females aged 20 - 65 years 3. 24-week availability |
| Key exclusion criteria | 1. Any pathology that is a contra-indication for rehabilitation training 2. Wheelchair dependency 3. No present physiotherapy (preferably) |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Guffenslaan 39
Hasselt
B-3500
Belgium
B-3500
Belgium
Sponsor information
IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium)
Research organisation
Research organisation
Bischoffsheimlaan 25
Brussel
B-1000
Belgium
| Website | http://www.iwt.be/ |
|---|---|
"ROR" |
https://ror.org/032xdry56 |
Funders
Funder type
Research organisation
IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium) (ref: 050078)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
