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Robot Therapy for Rehabilitation of Hand Movement After Stroke

Robot Therapy for Rehabilitation of Hand Movement After Stroke

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04536987
Acronym
HEXORR
Enrollment
15
Registered
2020-09-03
Start date
2012-10-04
Completion date
2017-01-15
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiparesis, Movement Disorders, Stroke

Keywords

robotic therapy, finger, hand

Brief summary

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.

Detailed 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.

Interventions

DEVICEHEXORR

The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.

Sponsors

MedStar National Rehabilitation Network
CollaboratorOTHER
The Catholic University of America
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Staff performing clinical evaluations was unaware of the study design.

Intervention model description

Random assignment to two study groups

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. a diagnosis of stroke more than 6 months prior to randomization 2. 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 3. adequate cognitive status, as determined by Mini-Mental Status Examination score \>24

Exclusion criteria

1. were under the influence of oral or injected antispasticity medications during the study 2. had MCP and IP passive extension limit \> 30 degrees from full extension 3. had pain that interfered with daily activities 4. had excessive tone in the fingers and thumb as determined by Ashworth scores \>=3 5. had severe sensory loss or hemispatial neglect as determined by clinical exam.

Design outcomes

Primary

MeasureTime frameDescription
Change in Fugl-Meyer Test of Motor Function6 month follow-upMeasures motor impairment in the upper extremity after stroke

Secondary

MeasureTime frameDescription
Change in Action Research Arm Test6 month follow-upMeasures functional limitations of the upper extremity
Change in finger extension range of motion (degrees)6 month follow-upMotion capture of finger and thumb movement will be used to assess extension ability in units of degrees. The task will be to open the hand as far as possible from a closed fist. Data from all digits will be averaged to provide a single metric for extension ability of the fingers and thumb.
Change in Modified Ashworth Test6 month follow-upMeasures hypertonia in the flexors of the fingers, wrist and elbow joints
Change in Motor Activity Log6 month follow-upMeasures the amount of use of the upper extremity in ADL
Change in Grip Strength6 month follow-upJamar Dynamometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026