Clinical trial NCT02747433: Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke
Official title: Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: robot-assisted therapy
task-oriented training
motor learning
cognitive strategy training
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline in Wolf Motor Function Test (WMFT)
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale
timeFrame: Baseline and 1-month follow-up
Secondary outcomes:
measure: Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline on Modified Ashworth Scale (MAS)
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery
timeFrame: Baseline and 1-month follow-up
measure: Change From Baseline in Movement Time During Reach-to-Target Task
timeFrame: Baseline and immediately after 6-week intervention
measure: Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task
timeFrame: Baseline and immediately after 6-week intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: MGH Institute of Health Professions & Spaulding Rehabilitation Hospital
name: Susan E Fasoli, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spaulding Rehabilitation Hospital & Harvard Medical School
name: Paolo Bonato, PhD
role: STUDY_CHAIR
References:
citation: Adans-Dester C, Fasoli SE, Fabara E, Menard N, Fox AB, Severini G, Bonato P. Can kinematic parameters of 3D reach-to-target movements be used as a proxy for clinical outcome measures in chronic stroke rehabilitation? An exploratory study. J Neuroeng Rehabil. 2020 Aug 8;17(1):106. doi: 10.1186/s12984-020-00730-1.