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Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Primary Purpose

Upper Limb Rehabilitation

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Robot assisted upper limb rehabilitation

About this trial

This is an interventional treatment trial for Upper Limb Rehabilitation focused on measuring stroke, upper limb, Joint coordination

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Exclusion Criteria:

Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:

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.).

Sites / Locations

The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

subacute device assisted group

subacute conventional group

chronic device assisted group

Arm Description

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA) of the Upper Limb before the training

Fugl-Meyer Assessment (FMA) of the Upper Limb after the training

Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up

Secondary Outcome Measures

Modified Ashworth Scale (MAS)

Action Research Arm Test (ARAT)

Full Information

NCT ID

NCT03752775

First Posted

November 20, 2018

Last Updated

August 23, 2022

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT03752775

Brief Title

Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Official Title

Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Limb Rehabilitation

Keywords

stroke, upper limb, Joint coordination

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

subacute device assisted group

Arm Type

Experimental

Arm Title

subacute conventional group

Arm Type

Active Comparator

Arm Title

chronic device assisted group

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Robot assisted upper limb rehabilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fugl-Meyer Assessment (FMA) of the Upper Limb before the training

Time Frame

For each subject, the FMA score will be measured one day before the training.

Title

Fugl-Meyer Assessment (FMA) of the Upper Limb after the training

Time Frame

For each subject, the FMA score will be measured one day after the 20-session training program.

Title

Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up

Time Frame

For each subject, the FMA score will be measured 3 months later after the last day of the training.

Secondary Outcome Measure Information:

Title

Modified Ashworth Scale (MAS)

Time Frame

For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.

Title

Action Research Arm Test (ARAT)

Time Frame

For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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) Exclusion Criteria: Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions: 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.).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoling Hu, PhD

Phone

34003206

xiaoling.hu@polyu.edu.hk

Facility Information:

Facility Name

The Hong Kong Polytechnic University

City

Hong Kong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoling Hu, Ph.D.

Phone

+852 34003205

xiaoling.hu@polyu.edu.hk

First Name & Middle Initial & Last Name & Degree

Xiaoling Hu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34526058

Citation

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.

Results Reference

derived

PubMed Identifier

33271057

Citation

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.

Results Reference

derived

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Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

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