Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
050078 IWT TETRA
Study information
Scientific title
Rehabilitation of functional muscle and motor capacity in neurodegenerative disease: a single centre placebo-controlled Multiple Sclerosis research trial
Acronym
MS rehabilitation
Study hypothesis
Regular and moderately intense rehabilitation of muscle strength improves functional capacity in multiple sclerosis (MS) patients.
Ethics approval
Ethics Board of Hasselt University approved on the 24th October 2005 (ref: CME 2005/233)
Study design
Single centre placebo-controlled clinical research trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/11/2005
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 patients subjected to four different rehabilitation modes
Participant exclusion criteria
1. Any pathology that is a contra-indication for rehabilitation training
2. Wheelchair dependency
3. No present physiotherapy (preferably)
Recruitment start date
01/11/2005
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Belgium
Trial participating centre
Guffenslaan 39
Hasselt
B-3500
Belgium
Sponsor information
Organisation
IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium)
Sponsor details
Bischoffsheimlaan 25
Brussel
B-1000
Belgium
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
IWT Vlaanderen (Instituut voor de aanmoediging van Innovatie door Wetenschap en Technologie in Vlaanderen) (Belgium) (ref: 050078)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list