Robot Aided Rehabilitation - Intervention



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:12/16/2018
Start Date:October 14, 2018
End Date:September 30, 2020
Contact:Chunyang Zhang, M.D.
Email:ChunyangZhang@som.umaryland.edu
Phone:(410) 706-8625

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

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.

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.

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
We found this trial at
1
site
621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Phone: 410-706-8625
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