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Robot Aided Rehabilitation - Intervention (Aim2&3)

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ClinicalTrials.gov Identifier: NCT02359253
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
National Institute on Disability, Independent Living, and Rehabilitation Research
North Carolina State University
Information provided by (Responsible Party):
Li-Qun Zhang, University of Maryland

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points [ Time Frame: 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 :
  1. Changes from baseline Fugl-Meyer Upper Extremity at two time points [ Time Frame: 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.

  2. Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points [ Time Frame: 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.

  3. Changes from baseline Modified Ashworth Scale (MAS) at two time points [ Time Frame: 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.

  4. Changes from baseline Action Research Arm Test (ARAT) at two time points [ Time Frame: 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.

  5. Changes from baseline Grip Strength & Pinch Strength at two time points [ Time Frame: 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.

  6. Changes from baseline Nottingham Sensory Assessment at two time points [ Time Frame: 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.

  7. Changes from baseline range of motion (ROM) at two time points [ Time Frame: 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.

  8. Changes from baseline spasticity at two time points [ Time Frame: 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.

  9. Changes from baseline relaxation time of the finger flexor muscles at two time points [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359253


Contacts
Contact: Chunyang Zhang, M.D. (410) 706-8625 ChunyangZhang@som.umaryland.edu
Contact: Kyung Koh, Ph.D. (410) 706-8625 KKoh@som.umaryland.edu

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Chunyang Zhang, OT    410-706-8625    ChunyangZhang@som.umaryland.edu   
Contact: Kyung Koh, Ph.D.    (410) 706-8625    KKoh@som.umaryland.edu   
Sub-Investigator: Derek Kamper, Ph.D.         
Sponsors and Collaborators
University of Maryland
National Institute on Disability, Independent Living, and Rehabilitation Research
North Carolina State University
Investigators
Principal Investigator: Li-Qun Zhang, Ph.D. University of Maryland

Publications:
Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. Review. Erratum in: Circulation. 2013 Jan 1;127(1):doi:10.1161/CIR.0b013e31828124ad. Circulation. 2013 Jun 11;127(23):e841.
Shumway-Cook A, Woollacott MH (2001) Motor Control: Theory and Practical Applications, 2nd ed. vol. Chapter 6. Philadelphia: Lippincott Williams & Wilkins.
Zhang LQ, Xu D, Kang SH, Roth EJ, Ren Y. Multi-Joint Somatosensory Assessment in Patients Post Stroke. BMES Ann Meeting, Phoenix. 2017.

Responsible Party: Li-Qun Zhang, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02359253     History of Changes
Other Study ID Numbers: HP-00076764
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li-Qun Zhang, University of Maryland:
Stroke
Spasticity
Arm
Hand
Robotic therapy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases