Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
NCT ID: NCT03752775
Last Updated: 2024-01-30
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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RECRUITING
NA
45 participants
INTERVENTIONAL
2018-11-01
2025-08-31
Brief Summary
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Detailed Description
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The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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subacute device assisted group
Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
subacute conventional group
Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
chronic device assisted group
Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
Interventions
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Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
Eligibility Criteria
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Inclusion Criteria
* Two weeks after the onset of stroke, however less than 0.5 year
* Mini-Mental State Examination (MMSE)\>21
* Able to sit up for at least 1 hour
* Fugl-Meyer Assessment (FMA) upper limb \<30
* Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3
* Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
For the chronic device assisted group:
* At least 0.5 year after the onset of stroke
* Mini-Mental State Examination (MMSE)\>21
* Able to sit up for at least 1 hour
* Fugl-Meyer Assessment (FMA) upper limb \<30
* Modified Ashworth Score (MAS) at the elbow, wrist and fingers \<3
* Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
* Currently pregnant
* Dysphasia (language deficiency)
* Post-stroke neglect
* Pacemaker implantation,
* Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
* The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
18 Years
70 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Xiaoling Hu
Principal Investigator
Locations
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The Hong Kong Polytechnic University
Hong Kong, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Nam C, Zhang B, Chow T, Ye F, Huang Y, Guo Z, Li W, Rong W, Hu X, Poon W. Home-based self-help telerehabilitation of the upper limb assisted by an electromyography-driven wrist/hand exoneuromusculoskeleton after stroke. J Neuroeng Rehabil. 2021 Sep 15;18(1):137. doi: 10.1186/s12984-021-00930-3.
Nam C, Rong W, Li W, Cheung C, Ngai W, Cheung T, Pang M, Li L, Hu J, Wai H, Hu X. An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. Soft Robot. 2022 Feb;9(1):14-35. doi: 10.1089/soro.2020.0090. Epub 2020 Dec 3.
Other Identifiers
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ITS/073/16
Identifier Type: -
Identifier Source: org_study_id
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