Health TrialsbyHealthPanel

Robot Aided Rehabilitation - Intervention

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Passive stretching

    Other intervention

    Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.

  • Passive movement

    Other intervention

    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.

  • IntelliArm

    Other intervention

    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.

  • Hand robot

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: IntelliArm with passive stretchingExperimental treatment 2 interventions
Group B: IntelliArm with passive movementExperimental treatment 2 interventions
Group C: The hand robot with passive stretchingExperimental treatment 2 interventions
Group D: The hand robot with passive movementExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points

The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.

Time frame
Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention

Secondary outcomes

1

Changes from baseline Fugl-Meyer Upper Extremity at two time points

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.

Time frame
Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
2

Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points

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.

Time frame
Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
3

Changes from baseline Modified Ashworth Scale (MAS) at two time points

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.

Time frame
Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
4

Changes from baseline Action Research Arm Test (ARAT) at two time points

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.

Time frame
Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

North Carolina State University

Collaborator

Source ClinicalTrials.gov
Apply now