Rehabilitation Robotics, Cognitive Skills Training and Function

Mass General Brigham

Status: Terminated

Conditions: Cerebrovascular Accident; Stroke

Treatments: Behavioral: Robot + Active Learning Program(RT-ALPS); Behavioral: Robot-Assisted Therapy (RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03599544

2018P001182

AOTFIRG18FASOLI (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Research has shown that robot-assisted therapy can help people regain control of simple reaching or grasping movements, but these improvements don't generalize well to use of the weaker limb during everyday tasks.

This study aims to refine and test a protocol named the Active Learning Program for Stroke (ALPS), which teaches people to use active problem solving strategies and a home program to improve function. Therapist-delivered ALPS instruction may incorporate use of strategies (e.g. STOP, THINK, DO, CHECK) modeled after the Cognitive Orientation for daily Occupational Performance (CO-OP) approach to improve real-world use of the paretic upper limb. We will evaluate whether the combination of robot-assisted therapy and ALPS training leads to better satisfaction and functional use of the weaker arm in persons with motor impairments more than 6 months after stroke, as compared to robot-assisted therapy alone.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Robot-Assisted Therapy (RT)

Active Comparator group

Description:

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks.

Treatment:

Behavioral: Robot-Assisted Therapy (RT)

Robot + Active Learning Program(RT-ALPS)

Experimental group

Description:

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks plus training in active problem solving, analysis of performance, and goal-setting focused on the transfer of acquired motor skills to daily activities in the home and community.

Treatment:

Behavioral: Robot + Active Learning Program(RT-ALPS)