Clinical trial NCT02359253: Robot Aided Rehabilitation - Intervention
Official title: Robot-Aided Diagnosis, Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke: Aims 2&3
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Spasticity
Arm
Hand
Robotic therapy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: North Carolina State University
First posted: 2015-02-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

* 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

Primary outcomes:
measure: Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points
timeFrame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
Secondary outcomes:
measure: Changes from baseline Fugl-Meyer Upper Extremity at two time points
timeFrame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention
measure: Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline Modified Ashworth Scale (MAS) at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline Action Research Arm Test (ARAT) at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline Grip Strength & Pinch Strength at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline Nottingham Sensory Assessment at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline range of motion (ROM) at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline spasticity at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
measure: Changes from baseline relaxation time of the finger flexor muscles at two time points
timeFrame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Li-Qun Zhang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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