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NCT Number: NCT03752775

Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

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.

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Key information

Conditions

Upper Limb Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

Location status: Recruiting

Location contact

Xiaoling Hu, Ph.D.

CONTACT

[email protected]

+852 34003205

Xiaoling Hu, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoling Hu, PhD

CONTACT

[email protected]

34003206

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2018
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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