Robot-Enhanced Stroke Therapy Optimizes Rehabilitation (RESTORE) (RESTORE)

December 19, 2019 updated by: Dr. Sean Dukelow, University of Calgary

Robot-Enhanced Stroke Therapy Optimized Rehabilitation

The purpose of this study is to investigate two aspects of robotic therapy after stroke. One goal is to determine if early robotic rehabilitation of the upper limb (beginning 5-9 days post-stroke) is more effective than later robotic rehabilitation (beginning 21-25 days post-stroke). The other goal is to determine if higher intensity robotic rehabilitation (2 hours/day) is more effective than lower intensity robotic rehabilitation (1 hour/day).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Medically stable stroke subjects will be recruited in the first few days following their stroke. All participants will complete clinical and robotic assessments of neurologic function at 7 time points. Therapy will occur daily (Monday through Friday) for 20 days.

Study participants will be randomly assigned to 1) start robot therapy early or late after stroke and 2)receive one or two hours of robot therapy per treatment day for four weeks, or 3) control group that will receive the current standard of care.

The participant's chart will be reviewed for information about their stroke and related health effects and medical treatments. Assessment points to track progress will occur at 7, 18, 31,44,90,180, and 365 days after a stroke for all groups (give or take 2 days to account for weekends and holidays).

Standard clinical assessments of neurologic function will be done at each assessment point and include: cognition, arm strength, muscle tone, spasticity, reflexes, dexterity, visual acuity and fields, the Behavioural Inattention Test, and tests of arm movement (Fugl-Meyer Upper-Extremity, Box and Block Test, Chedoke-McMaster Stroke Assessment, and the Action Research Arm Test). These assessments can usually be done in about an hour. The assessment may be done over two sessions if needed due to fatigue or scheduling conflicts.

Robotic therapy will be conducted using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, Bkin Technologies, Kingston, ON). It will include several different tasks, each designed to train aspects of sensorimotor function of the proximal upper limb. Task performance will be monitored and difficulty will increase within and between sessions. The majority of the investigator's methods have been used previously to achieve equivalent or superior outcomes to standard rehabilitation.

Robotic assessment will measure elbow and shoulder range of motion, reaching for targets, the ability to mirror match the position of an arm with the other arm, and the ability to use both arms to hit away moving targets. The robotic assessment will take approximately 1.5 hours.

Robotic tasks include:

Visually guided reaching with assistance or resistance; Virtual Soccer; Shape Tracking; Whack-a-mole; Table Tennis Task; Ball on Bar Task; Proprioceptive Reaching; Hand Ball; Proprioceptive Shape Tracking.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Recruiting
        • Foothills Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent first stroke (ischemic or hemorrhagic)
  • Upper extremity Fugl-Meyer score 15-45
  • Modified Ashworth score of shoulder/elbow less than or equal to 2
  • Able to follow task instructions
  • Visual acuity better than 20/50 in both eyes
  • Able to give consent
  • Able to commit to follow-up

Exclusion Criteria:

  • Prior stroke or significant neurologic problem (e.g. Multiple Sclerosis)
  • Pre-existing musculoskeletal injury that will interfere with active therapy
  • Pre-Stroke Modified Rankin Score > 2
  • Clinical evidence of Unilateral Spatial Neglect on the Behavioural Inattention Test (BIT)
  • Enrollment in a concurrent clinical intervention trial
  • Major co-morbid or concurrent illness such that improvement is unlikely or completion of the protocol as specified is unlikely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early Robotic Rehab Low Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive one hour of treatment per day for 20 days.
Device: Robotic exoskeleton
The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.
Other Names:
  • KINARM
Active Comparator: Early Robotic Rehab High Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
Device: Robotic exoskeleton
The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.
Other Names:
  • KINARM
Active Comparator: Late Robotic Rehab Low Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive one hour of treatment per day for 20 days.
Device: Robotic exoskeleton
The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.
Other Names:
  • KINARM
Active Comparator: Late Robotic Rehab High Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
Device: Robotic exoskeleton
The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.
Other Names:
  • KINARM
Active Comparator: Control Group
This group will receive usual care with robotic assessment.
Behavioral: Usual Care
This group will receive standard care with no additional therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer upper extremity motor function score (FMA)
Time Frame: From baseline to 44 days
FMA scores upper extremity motor impairment based on 22 items and scores range from 0 (completely plegic) to 66 (normal).
From baseline to 44 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: From baseline to 180 days
FIM rates subjects on 18 items across many functions such as eating, grooming, bathing and dressing on a scale from 1 (total assistance needed) to 7 (complete independence). Lowest possible score is 18 (lowest independence) and the best possible score is 126 (completely independent). The FIM is the standard measure used by rehabilitation facilities in Cananda and the United States to evaluate overall function and burden of care.
From baseline to 180 days
modified Rankin Scale (mRS)
Time Frame: From baseline to 180 days
The mRS is a disability rating scale from 0 (no symptoms at all) to 6 (deceased).
From baseline to 180 days
Action Research Arm Test (ARAT)
Time Frame: From baseline to 180 days
The ARAT assesses arm function to determine the quality of the arm movement, and the limitation of activity. The ARAT consists of 4 sub-tests; that examines and individual's grip, grasp, pinch and gross motor movement in order to determine upper extremity function. Objects of varying size, shape, and weight must be either grasped, handled or moved in a specific task in order to evaluate function. Low scores mean worse function with the minimum possible score being 0 and the highest possible score being 57 (normal function).
From baseline to 180 days
Robotic Assessments
Time Frame: From baseline to 180 days.
Robotic Assessments. The robotic assessment consists of a number of upper limb tests of neurologic function which have been validated against standard clinical measures. Tasks include: Range of Motion, Visually Guided Reaching, Limb Position Matching, Limb Kinesthesia, and Object Hit. These assessments use z-scores, based on normal distributions, as a measure of performance. Scores within 1.96 standard deviations away from 0 are considered normal and scores beyond 1.96 standard deviations are considered impaired.
From baseline to 180 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Queen's University

Investigators

  • Principal Investigator: Sean Dukelow, MD, PhD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB13-0414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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