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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Robot-Assisted Therapy (RT) Device
    Intervention Desc: Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community.
    ARM 1: Kind: Experimental
    Label: Robot-Assisted Therapy (RT)
    Description: Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training
  • Robot & Task-Oriented Training (RT-TOT) Device
    Intervention Desc: Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training will be delivered for remaining 30 mins of each treatment session. Robot and task oriented training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community.
    ARM 1: Kind: Experimental
    Label: Robot & Task-Oriented Training (RT-TOT)
    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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) Baseline, immediately after 6-week intervention; 1-month follow-up No
Primary Wolf Motor Function Test (WMFT) Baseline, immediately after 6-week intervention; 1-month follow-up No
Primary Confidence in Arm and Hand Movement (CAHM) scale Baseline, immediately after 6-week intervention; 1-month follow-up No
Secondary Motor Activity Log (MAL) Baseline, immediately after 6-week intervention; 1-month follow-up No
Secondary Home Based Accelerometry - Wearable Sensors Baseline, immediately after 6-week intervention; 1-month follow-up No
Secondary Kinematic data will be collected via 3-D motion capture (Vicon Motion Systems Ltd. UK) Baseline, immediately after 6-week intervention No
Secondary Surface EMG (SEMG) Baseline, immediately after 6-week intervention No
Secondary Modified Ashworth Scale (MAS) Baseline, immediately after 6-week intervention; 1-month follow-up No
Secondary Stroke Impact Scale (SIS) Baseline, immediately after 6-week intervention; 1-month follow-up No

Sponsors