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Clinical Trials/NCT02359253
NCT02359253
Recruiting
N/A

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

University of Maryland, Baltimore1 site in 1 country72 target enrollmentOctober 14, 2018
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Maryland, Baltimore
Enrollment
72
Locations
1
Primary Endpoint
Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
Status
Recruiting
Last Updated
9 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2018
End Date
December 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Li-Qun Zhang

Professor

University of Maryland, Baltimore

Eligibility 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

  • 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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • 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)
  • 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)
  • Changes from baseline spasticity at two time points(Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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