Health TrialsbyHealthPanel

Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

ConditionUpper Limb Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Currently pregnant

Dysphasia (language deficiency)

Post-stroke neglect

Pacemaker implantation,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: subacute device assisted groupExperimental treatment 1 intervention
Group B: subacute conventional groupActive comparator 1 intervention
Group C: chronic device assisted groupOther 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

Source ClinicalTrials.gov
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