Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

NCT ID: NCT03752775

Last Updated: 2024-01-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2025-08-31

Brief Summary

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A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

Detailed Description

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A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.

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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Upper Limb Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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subacute device assisted group

Group Type EXPERIMENTAL

Robot assisted upper limb rehabilitation

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Robot assisted upper limb rehabilitation

Intervention Type DEVICE

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

Group Type OTHER

Robot assisted upper limb rehabilitation

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

For the subacute groups:

* 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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoling Hu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoling Hu, PhD

Role: CONTACT

Facility Contacts

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Xiaoling Hu, Ph.D.

Role: primary

+852 34003205

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.

Reference Type DERIVED
PMID: 34526058 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33271057 (View on PubMed)

Other Identifiers

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ITS/073/16

Identifier Type: -

Identifier Source: org_study_id

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