Robot Therapy for Rehabilitation of Hand Movement After Stroke (HEXORR)

C

Catholic University of America (CUA)

Status and phase

Completed
Phase 2

Conditions

Stroke
Movement Disorders
Hemiparesis

Treatments

Device: HEXORR

Study type

Interventional

Funder types

Other

Identifiers

NCT04536987
2012-315

Details and patient eligibility

About

A study will be performed where individuals with chronic stroke will be randomly assigned to receive 2 different dosages of robotic hand therapy. One group will receive 12 sessions of robot-assisted repetitive movement practice in the HEXORR robot over a 4-5 week period. A second group will receive 24 sessions of HEXORR therapy over a 8-10 week period.

Full description

The overall goal of the proposed work is to improve hand function after stroke. Adequate hand function is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, involuntary activation of flexors and inability to activate extensors. The rationale for this approach stems from the growing evidence that neuro-rehabilitation after stroke may be enhanced via the application of motor learning strategies within the context of repetitive movement practice. The key therapeutic aspects of these strategies are high repetition, volitional effort, and successful completion of tasks to prevent frustration. While these represent promising therapeutic strategies, they are limited to mildly impaired subjects who already have enough control of finger extension to tolerate high repetitions of grasp/release tasks without succumbing to fatigue and/or frustration. There is a very large population of stroke patients who don't fall into this category and often must rely on compensatory strategies. In these patients, repetitive task practice facilitated by a robotic device may be more effective than unassisted task practice.

Enrollment

15 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • a diagnosis of stroke more than 6 months prior to randomization
  • presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
  • adequate cognitive status, as determined by Mini-Mental Status Examination score >24

Exclusion criteria

  • were under the influence of oral or injected antispasticity medications during the study
  • had MCP and IP passive extension limit > 30 degrees from full extension
  • had pain that interfered with daily activities
  • had excessive tone in the fingers and thumb as determined by Ashworth scores >=3
  • had severe sensory loss or hemispatial neglect as determined by clinical exam.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

15 participants in 2 patient groups

low-dosage robot therapy
Experimental group
Description:
12 sessions of robotic therapy over 4-5 weeks
Treatment:
Device: HEXORR
hi-dosage robot therapy
Experimental group
Description:
24 sessions of robotic therapy over 8-10 weeks
Treatment:
Device: HEXORR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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