Clinical trial NCT03599544: Rehabilitation Robotics, Cognitive Skills Training and Function
Official title: A Paradigm Sift: Rehabilitation Robotics, Cognitive Skills Training and Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Keywords: Upper limb function
Arm and hand weakness
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2018-07-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 10 weeks
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Stroke Impact Scale (SIS) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Home-based Accelerometry: Wearable Sensors at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Modified Ashworth Scale (MAS) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Time at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Canadian Occupational Performance Measure (COPM) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Stroke Impact Scale (SIS) at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Confidence in Arm and Hand Movement (CAHM) Scale at 10 weeks
timeFrame: Baseline and 10 weeks
measure: Change from Baseline Home-based Accelerometry: Wearable Sensors at 10 weeks
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Institute of Health Professions
state: Massachusetts
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: STUDY_CHAIR
References: