|- candidate number||4150|
|- NTR Number||NTR1464|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||30-sep-2008|
|- Secondary IDs||08.05.6.3 Roessingh Research and Development|
|- Public Title||Effect of intensive exercise therapy with and without gravity compensation on upper extremity function in subjects with chronic cervical spinal cord injury.|
|- Scientific Title||Effect of intensive exercise therapy with and without gravity compensation on upper extremity function in subjects with chronic cervical spinal cord injury.|
|- hypothesis||Gravity compensation in addition to intensive exercise therapy will result in a greater improvement in upper extremity function compared to intensive exercise practice without gravity compensation. |
|- Healt Condition(s) or Problem(s) studied||Upper extremity, Exercise therapy, Spinal Cord Injury, Cervical, Gravity compensation|
|- Inclusion criteria||1. Age 18 to 65; |
2. Stable spinal cord injury with level C5-C7 and with American Spinal cord Injury; Association (ASIA) Impairment Scale A, B and C;
3. At least one year since time of injury;
4. Able to follow an intensive exercise program;
|- Exclusion criteria||1. Extreme shoulder pain;|
2. Contractures upper extremity and/or spasticity preventing exercise therapy;
3. Cognitive/communicative impairments;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||31-mei-2009|
|- Target number of participants||10|
|- Interventions||A mechanical, passive device called Freebal will be used to counteract the influence of gravity on the upper extremity. An intensive exercise therapy program consisting of training of the upper extremity function for 1.5 hours 3 times a week will be applied 4 weeks with and 4 weeks without gravity compensation.|
|- Primary outcome||- Functional outcome measurements:|
* 2 times of the Van Lieshout Task
* 7 items of the Wolf Motor Function Task and the sf-QIF.
- Motor control parameters:
* EMG and movement tracking (Vicon)
|- Secondary outcome||N/A|
|- Timepoints||The subjects were tested at the start of the training, after 4 and 8 weeks of training and finaly an follow-up measurement after 4 weeks.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| M. Jannink|
|- CONTACT for SCIENTIFIC QUERIES|| M. Jannink|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|Ministry of Economic Affairs|
|- Publications||Not applicable|
|- Brief summary||Rationale: |
The consequences of Spinal Cord Injury (SCI) are diverse and complex. Subjects with a tetraplegia have impaired upper extremity function limiting the ability of individuals with cervical SCI to perform manual activities of daily living. Training of upper extremity function in tetraplegics is of great importance. Conventional training methods based on motor relearning principles require great physical effort from the patient which can limit the intensity of the training due to fatigue. New technological innovations in rehabilitation make it easier to control and report these variables. Studies have shown that by using a mechanical device to counteract the influence of gravity, active arm movements may be facilitated in stroke patients by reducing the required muscle activity to maintain a particular arm orientation. According to principles of motor relearning in stroke and SCI patients gravity compensation in addition to intensive exercise therapy could result in a greater improvement in upper extremity function.
To investigate the effect of gravity compensation in combination with intensive exercise therapy on upper extremity function in subjects with SCI. Hypothesis: gravity compensation in addition to intensive exercise therapy will result in a greater improvement in upper extremity function compared to intensive exercise therapy alone.
Cross-over, single blinded experimental design.
Ten subjects with chronic SCI, between 18-65 years old with SCI level C5-C7, ASIA A-C.
A mechanical, passive device called Freebal will be used to counteract the influence of gravity on the upper extremity. An intensive exercise therapy program consisting of training of the upper extremity function by an occupational therapist for one and a half hours three times a week will be applied with and without gravity compensation for the duration of two periods of four weeks.
Main study parameters/endpoints:
The main study parameter is the change in upper extremity function using two VLT tasks, seven WMFT tasks and the sf-QIF. Change in motor control parameters will be measured using surface EMG and VICON.
|- Main changes (audit trail)|
|- RECORD||30-sep-2008 - 8-okt-2008|