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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03020576 |
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Date of registration:
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10/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Robotic and Conventional Hand Therapy After Stroke
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Scientific title:
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Robot-assisted Hand Training (Amadeo) Compared With Conventional Physiotherapy Techniques in Chronic Ischemic Stroke Patients: A Pilot Study |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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31 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03020576 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Austria
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United States
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Contacts
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Name:
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Raimund Helbok, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Innsbruck Medical University |
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Name:
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Joel Stein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- history of stroke (>3 months from time of ictus)
- paresis or plegia of the upper extremity.
Exclusion Criteria:
- severe spasticity (defined on the Ashworth Scale with a score of 4-5)
- severe pain despite conventional pain therapy of the paretic upper extremity
- swelling, infection, fracture or ulcers of the paretic extremity
- arthritis of the hand joints
- pregnant
- botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
- severe contractions
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Device: Amadeo Hand Robot Device
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Other: Conventional Therapy
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Primary Outcome(s)
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Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer
[Time Frame: Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)]
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Secondary Outcome(s)
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Change in Hand and Pinch Strength
[Time Frame: Through study completion, an average of 8 weeks]
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Change in Range of Motion Measures
[Time Frame: Through study completion, an average of 8 weeks]
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Change in Motor Activity Log How Well
[Time Frame: Through study completion (taken at baseline and on 8 week study completion)]
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Change in Hand Dexterity
[Time Frame: Through study completion, an average of 8 weeks]
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Change in Motor Activity Log Amount
[Time Frame: Through study completion (taken at baseline and at 8-week study completion)]
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Change in Mobility and Activities of Daily Living
[Time Frame: Through study completion (taken at baseline and at 8 week study completion)]
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Change in Spasticity Measures
[Time Frame: Through study completion, an average of 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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