Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

Upper Limb Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03752775
• Other study ID #: ITS/073/16
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: Xiaoling Hu, PhD
• Phone: 34003206
• Email: xiaoling.hu[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Stroke
• Upper Limb Rehabilitation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.