Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Upper Limb Rehabilitation

Treatments: Device: Robot assisted upper limb rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03752775

ITS/073/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

subacute device assisted group

Experimental group

Treatment:

Device: Robot assisted upper limb rehabilitation

subacute conventional group

Active Comparator group

Treatment:

Device: Robot assisted upper limb rehabilitation

chronic device assisted group

Other group

Treatment:

Device: Robot assisted upper limb rehabilitation