Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke (ALPS)

Mass General Brigham

Status: Completed

Conditions: Stroke

Treatments: Device: Robot-Assisted Therapy (RT); Device: Robot & Task-Oriented Training (RT-TOT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02747433

2015P002107

Details and patient eligibility

About

Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.

Full description

Little is known about how individuals learn to utilize robot-trained movements during upper extremity (UE) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. Systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved UE performance during daily tasks and occupations. These findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. These principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.

Enrollment: 11 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow & hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
• Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)12 during 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
• Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
• Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
• 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
• Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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11 participants in 2 patient groups

ALPS + Robot-Assisted Therapy (RT)

Active Comparator group

Description:

Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training

Treatment:

Device: Robot-Assisted Therapy (RT)

ALPS + Robot + Task-Oriented Training (RT-TOT)

Active Comparator group

Description:

Armeo and Amadeo robot-assisted intensive upper extremity therapy 30 mins, 3x week for 6 weeks plus ALPS training. Task oriented training will be provided for remaining 30 min of each treatment session

Treatment:

Device: Robot & Task-Oriented Training (RT-TOT)