Rehabilitation Robotics, Cognitive Skills Training and Function

Stopped early · Not applicable

Conditions studied: Stroke, Cerebrovascular Accident

In brief

This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.

Key facts

Study ID

NCT03599544

Run by

Spaulding Rehabilitation Hospital

People needed

6

Starts

2019-06-06

Expected to finish

2020-03-03

Last updated by the study team

2023-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
• Stroke type will include both ischemic and hemorrhagic stroke.
• Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
• Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)during the initial evaluation visit

You may not qualify if…

• No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) [13]
• Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale [15];
• Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test [16]
• Aphasia sufficient to limit comprehension and completion of the treatment protocol
• Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
• Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
• Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE

Where it is running

• MGH Institute of Health Professions — Boston, Massachusetts, United States
• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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