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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1464 |
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Date of registration:
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30/09/2008 |
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Primary sponsor: |
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Public title:
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Effect of intensive exercise therapy with and without gravity compensation on upper extremity function in subjects with chronic cervical spinal cord injury.
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Scientific title:
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Effect of intensive exercise therapy with and without gravity compensation on upper extremity function in subjects with chronic cervical spinal cord injury. - FzCompSCI |
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Date of first enrolment:
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1/6/2008 |
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Target sample size:
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10 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1464 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Crossover; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Jannink |
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Address:
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[default]
The Netherlands |
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Telephone:
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Email:
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m.jannink@rrd.nl |
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Affiliation:
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Name:
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M.
Jannink |
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Address:
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[default]
The Netherlands |
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Telephone:
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Email:
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m.jannink@rrd.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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;
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Upper extremity, Exercise therapy, Spinal Cord Injury, Cervical, Gravity compensation
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Intervention(s)
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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.
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Primary Outcome(s)
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- 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)
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Secondary ID(s)
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08.05.6.3
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Source(s) of Monetary Support
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Ministry of Economic Affairs
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