Robot-Enhanced Stroke Therapy Optimizes Rehabilitation (RESTORE)

Study Overview
=================
Brief Summary
-----------------
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).

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.

Official Title
-----------------
Robot-Enhanced Stroke Therapy Optimized Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Robotic exoskeleton
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Robotic Rehab Low Intensity<br>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<br>* 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.<br>* Other names: KINARM;|
| Active Comparator: Early Robotic Rehab High Intensity<br>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<br>* 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.<br>* Other names: KINARM;|
| Active Comparator: Late Robotic Rehab Low Intensity<br>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<br>* 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.<br>* Other names: KINARM;|
| Active Comparator: Late Robotic Rehab High Intensity<br>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<br>* 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.<br>* Other names: KINARM;|
| Active Comparator: Control Group<br>This group will receive usual care with robotic assessment. | Behavioral: Usual Care<br>* This group will receive standard care with no additional therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer upper extremity motor function score (FMA) | 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) | 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) | 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) | 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 | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Stroke Rehabilitation, Robotic Exoskeleton