Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

NCT03752775 | Unknown DMC

• 1 other identifier: ITS/073/16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Rehabilitation

Keywords

stroke; upper limb; Joint coordination

Outcome Measures

Primary Outcomes (3)

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

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

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

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

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

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

Secondary Outcomes (2)

• Modified Ashworth Scale (MAS)

  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.

• Action Research Arm Test (ARAT)

  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.

Study Arms (3)

subacute device assisted group

EXPERIMENTAL

Device: Robot assisted upper limb rehabilitation

subacute conventional group

ACTIVE COMPARATOR

Device: Robot assisted upper limb rehabilitation

chronic device assisted group

OTHER

Device: Robot assisted upper limb rehabilitation

Interventions

Robot assisted upper limb rehabilitation 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; subacute conventional group; subacute device assisted group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34526058 DERIVED

• 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.

  PMID: 33271057 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiaoling Hu, PhD

CONTACT

34003206; xiaoling.hu@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)