Aim2&3: Robot Aided Rehabilitation - Intervention

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Recruiting

CT.gov ID

NCT02359253

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed), North Carolina State University (Other)

Enrollment

Location

Arms

62.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Passive stretching Other: Passive movement Other: IntelliArm Other: Hand robot	N/A

Detailed Description

Sensorimotor impairments following stroke can lead to substantial disability involving the upper extremity. These impairments often involve complex pathological changes across multiple joints and multiple degrees-of-freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. Many potential mechanisms, such as weakness, motoneuronal hyperexcitability, and elevated passive impedance, can contribute and it is currently unclear where to focus treatment. The objectives of this study are to address allocation of therapy resources between the arm and hand and to examine the benefits of combining passive stretching with active movement training.

Aim 1. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.

Hypothesis 1: Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone.

Aim 2. To examine the efficacy of combining passive stretching with active (assistive or resistive) training for the shoulder, elbow, wrist, and hand.

Hypothesis 2: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone.

Subjects will be assigned randomly with equal chance to one of four groups. Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups. Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups. Arm-training groups will use the IntelliArm, hand-training groups will use the hand robot. For those assigned to the stretching groups, subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot. For those assigned to the passive movement condition, subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session. For each group, the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot (depending on group assignment), for a total session time of 75-90 minutes.

The 4 groups of subjects will be compared against each other.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Robot-Aided Diagnosis, Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke: Aims 2&3

Actual Study Start Date :

Oct 14, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IntelliArm with passive stretching Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.	Other: Passive stretching Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion. Other: IntelliArm During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
Experimental: IntelliArm with passive movement Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.	Other: Passive movement Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces. Other: IntelliArm During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
Experimental: The hand robot with passive stretching Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.	Other: Passive stretching Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion. Other: Hand robot During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.
Experimental: The hand robot with passive movement Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.	Other: Passive movement Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces. Other: Hand robot During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.

Outcome Measures

Primary Outcome Measures

Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points [Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention]
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.

Secondary Outcome Measures

Changes from baseline Fugl-Meyer Upper Extremity at two time points [Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention]
The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
The Chedoke-McMaster Stroke Assessment (CMSA) is a screening and assessment tool utilized to measure physical impairment and activity of an individual following a stroke. The Chedoke Arm and Hand Activity Inventory (CAHAI) is used to assess functional ability of the paretic arm and hand. Each domain is scored on a 7-point scale.
Changes from baseline Modified Ashworth Scale (MAS) at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Changes from baseline Action Research Arm Test (ARAT) at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
ARAT assesses the ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
Changes from baseline Grip Strength & Pinch Strength at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
A dynamometer is used to measure grip strength and a pinch gauge to measure tip, key, and palmar pinch.
Changes from baseline Nottingham Sensory Assessment at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
The assessment tests the tactile sensation of the patient through light touch, pressure and pinprick.
Changes from baseline range of motion (ROM) at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
The range of motion (ROM) of shoulder, elbow, wrist and fingers will be measured in Degree.
Changes from baseline spasticity at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
Spasticity will be measured by the resistance torque in Newton-meter under controlled movement at each joint.
Changes from baseline relaxation time of the finger flexor muscles at two time points [Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
Relaxation time will be quantified in Second by examining flexor muscle activity. The subject will be instructed to grip maximally upon hearing an audible tone. The subject should then relax his/her grip as quickly as possible after hearing a second tone. The relaxation time is defined as the elapsed time in Second from the second tone to the point at which the flexor muscle magnitude returns to the baseline level + three standard deviations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First focal unilateral lesion, ischemic or hemorrhagic
Had a stroke 1-12 months prior to enrollment
Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

Exclusion Criteria:

Apraxia
Score of less than 22 on the Mini Mental Status Exam
Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
Severe contracture in the upper extremity
Unable to sit in a chair for 3 consecutive hours
Unrelated musculoskeletal injuries
Poor fit into equipment used in study
Botox injection in upper extremity within 4 months
Concurrent participation in gait or upper extremity intervention studies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

University of Maryland, Baltimore
National Institute on Disability, Independent Living, and Rehabilitation Research
North Carolina State University

Investigators

Principal Investigator: Li-Qun Zhang, Ph.D., University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Li-Qun Zhang, Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT02359253

Other Study ID Numbers:

HP-00076764

First Posted:

Feb 9, 2015

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Li-Qun Zhang, Professor, University of Maryland, Baltimore

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Jan 26, 2022