|- candidate number||8806|
|- NTR Number||NTR2661|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-dec-2010|
|- Secondary IDs||7936 MIAS AAD Euregio|
|- Public Title||Shoulder load and daily activities compared between power assisted and manual wheelchair propulsion.|
|- Scientific Title||Shoulder load and daily activities compared between power assisted and manual wheelchair propulsion.|
|- hypothesis||Because the force needed to propel the wheelchair is partly delivered by a motor, we hypothesized that the forces and moments exerted on the rim will decrease. Consequently, forces and moments at the glenohumeral joint and muscle activation of push phase muscles will decrease. Less contact time on the rim will be necessary to generate enough torque to propel the wheelchair, which will result in a lower propulsion frequency and smaller glenohumeral joint angles. In addition wheelchair propulsion requires less effort with power assist which will result in a longer distance travelled and more involvements in social activities.|
|- Healt Condition(s) or Problem(s) studied||Upper extremity, Manual wheelchair users, Restricted arm-hand function|
|- Inclusion criteria||1. Manual wheelchair user for at least one year due to a neurological disorder;|
2. Medically and physically stable, judged by subjects own physician;
3. The upper limbs might be affected; however, they should be able to propel a manual wheelchair bimanually;
4. Able to maintain posture (trunk stability);
5. Age 18 to 65;
6. Subjects should be able to use their usual mode of transportation with the power assisted wheels;
7. Their wheelchair fitted with power assist wheels.
|- Exclusion criteria||1. Use of any type of power assisted wheelchairs;|
2. Extreme shoulder pain, contractures upper extremity and/or spasticity which made manual wheelchair propulsion for the duration of the measurements impossible;
3. Cognitive or communicative impairments which made cooperation with the study protocol compromised.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-feb-2013|
|- Target number of participants||20|
|- Interventions||The applied intervention is a set of power assist wheels which we place on the participants own manual wheelchair for four weeks.|
|- Primary outcome||To assess if the forces and moments acting on the shoulder are lower during power assisted wheelchair propulsion compared to manual wheelchair propulsion, related to perceived load of the upper extremity (VAS-score) and objectively measured with the oxygen uptake within six minutes.|
|- Secondary outcome||To determine the differences between power assisted wheelchair and manual wheelchair propulsion on the three levels of the ICF model:|
1. ICF: Body functions and structure:
A. Is the intensity, frequency and influence of shoulder pain on daily activities different during four weeks of power assisted wheelchair use compared to four weeks of manual wheelchair use?
2. ICF: Activity:
A. Is the use of a wheelchair during a day (travelled distance, time, and velocity) different during four weeks power assisted wheelchair use compared to four weeks manual wheelchair use?
B. Are wheelchair skills influenced by the power assisted wheelchair, compared to the manual wheelchair?
3. ICF: Participation:
A. Is community participation and self efficacy different during four weeks power assisted wheelchair use compared to four weeks manual wheelchair use?
B. Are the participants satisfied with the power assisted wheelchair?
|- Timepoints||4 weeks of own manual wheelchair use and 4 weeks power assisted wheelchair use:|
1. Intensity and frequency of shoulder pain (daily VAS);
2. Daily time and distance travelled (registered by means of a reedcontact);
3. Performed activities (daily questionnaire);
Measurements at Roessingh Research and Development (RRD):
A. Shoulder load;
B. Biomechanical analysis upper extremity; Force and torque sensor at the wheelaxis;
C. Wheelchair skills test;
D. Questionnaires: WUSPI, SEWMS, D-QUEST.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Marieke Kloosterman|
|- CONTACT for SCIENTIFIC QUERIES|| Marieke Kloosterman|
|- Sponsor/Initiator ||Roessingh Research and Development|
(Source(s) of Monetary or Material Support)
|- Brief summary||Objective: |
The primary objective is to compare forces and moments acting on the shoulder of manual wheelchair users during power assisted wheelchair propulsion and manual wheelchair propulsion.
The secondary objectives are to assess the differences between power assist wheelchair propulsion and manual wheelchair propulsion on (a) the intensity and frequency of shoulder pain, (b) activity during a day, (c) community participation and quality of life.
This study is a longitudinal experimental study.
20 manual wheelchair users.
The applied intervention is a set of power assist wheels which are placed on participants own manual wheelchair. During one measurement an instrumented wheelchair with a force and torque sensor in the wheel axis is used.
Main study parameters/endpoints:
Main study parameter is shoulder load. Secondary study parameters were intensity and frequency of shoulder pain; distance, velocity and time daily travelled; wheelchair skills; energy expenditure; community participation, and quality of life; opinion about the power assisted wheelchair.
|- Main changes (audit trail)|
|- RECORD||21-dec-2010 - 29-mei-2011|