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

NCT02747433 | Completed Results

• 1 other identifier: 2015P002107
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

robot-assisted therapy; task-oriented training; motor learning; cognitive strategy training

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest

  The FMA will examine changes in motor function, pain and sensation in the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The FMA upper extremity subtest contains 33 items, scored as 0= unable, 1=partial ability, 2= faultless with a total possible score of 66 points. Change was calculated as the value at the 1 month follow-up assessment minus the value at baseline to reflect retention of motor function following intervention.

  Baseline and 1-month follow-up

• Change From Baseline in Wolf Motor Function Test (WMFT)

  The WMFT examined changes in ability to complete timed, functionally-based activities with the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The task rate was calculated as the average # of times that each test item could be completed within 1 minute. Here we report the change in task rate scores between admission and 1 month follow-up assessments to reflect retention of motor function following intervention. A higher number indicates improved task completion.

  Baseline and 1-month follow-up

• Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale

  The CAHM is a self-report assessment in which participants are asked to rate their confidence (0-100%) in successfully using their paretic UE for a variety of everyday activities. Change in confidence ratings between baseline, post-intervention and 1-month follow up assessments were examined. A higher score indicates greater confidence. We report change scores between admission and 1 month follow up assessments to reflect retention of scores following intervention.

  Baseline and 1-month follow-up

Secondary Outcomes (7)

• Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale

  Baseline and 1-month follow-up

• Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale

  Baseline and 1-month follow-up

• Change From Baseline on Modified Ashworth Scale (MAS)

  Baseline and 1-month follow-up

• Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain

  Baseline and 1-month follow-up

• Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery

  Baseline and 1-month follow-up

Study Arms (2)

ALPS + Robot-Assisted Therapy (RT)

ACTIVE COMPARATOR

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

Device: Robot-Assisted Therapy (RT)

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

ACTIVE COMPARATOR

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

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

Interventions

Robot-Assisted Therapy (RT) DEVICE

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.

ALPS + Robot-Assisted Therapy (RT)

Robot & Task-Oriented Training (RT-TOT) DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Related Publications (1)

• 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.

  PMID: 32771020 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

We are unable to report results of accelerometer data due to technical problems.Surface electromyography (EMG) during reach-to-target kinematic assessment was collected for a separate study by Dr. Bonato and has not been analyzed by co-investigators.

Results Point of Contact

• Title: Susan Fasoli, ScD OTR/L, Associate Professor
• Organization: MGH Institute of Health Professions

sfasoli@mghihp.edu

617-643-4777

Study Officials

• Susan E Fasoli, ScD

  MGH Institute of Health Professions & Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital & Harvard Medical School

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind study.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MGH Institute of Health Professions

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: July 1, 2016
• Primary Completion: November 10, 2018
• Study Completion: December 1, 2018
• Last Updated: May 31, 2022
• Results First Posted: April 9, 2020

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)