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Clinical Trials/NCT03752775
NCT03752775
Recruiting
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country45 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Upper Limb Rehabilitation
Sponsor
The Hong Kong Polytechnic University
Enrollment
45
Locations
1
Primary Endpoint
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
August 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaoling Hu

Principal Investigator

The Hong Kong Polytechnic University

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

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.).

Outcomes

Primary Outcomes

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.

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.

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 Outcomes

  • 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 Sites (1)

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