Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke
NCT ID: NCT04436627
Last Updated: 2021-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
35 participants
INTERVENTIONAL
2020-02-07
2022-12-31
Brief Summary
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Detailed Description
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The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II\~III /10 for stage IV /15 for stage V\~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mild severity:
Brunnstrom stage of distal part: 5-6
Amadeo-assisted training-1
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training.
Moderate severity:
Brunnstrom stage of distal part: 4
Amadeo-assisted training-2
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release).
severe severity:
Brunnstrom stage of distal part: 2-3
Amadeo-assisted training-3
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot.
Interventions
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Amadeo-assisted training-1
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training.
Amadeo-assisted training-2
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release).
Amadeo-assisted training-3
Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot.
Eligibility Criteria
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Inclusion Criteria
* (2) Twenty years old or older
* (3) Modified Ashworth Scale of proximal UE ≤ 3 (shoulder and elbow), and Modified Ashworth Scale of distal UE ≤ 2 (wrist and fingers)
* (4) UE subscale of Fugl-Meyer Assessment score \< 60
* (5) Cognitive test with the Mini Mental State Examination ≥ 21
* (6) Can provide informed consent
Exclusion Criteria
* (2) Absence of proprioception in the wrist and hand
* (3) Other neurological or psychological disorders, e.g. Parkinson's disease
* (4) Receiving Botulinum toxin injections within 3 months
* (5) Enrolling in other rehabilitation experiments or drug studies within 3 months
* (6) unable to operate the AMADEO training system or who may have safety concern
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Ching-yi Wu, ScD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201901693A3
Identifier Type: -
Identifier Source: org_study_id
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