Clinical trial NCT04536987: Robot Therapy for Rehabilitation of Hand Movement After Stroke
Official title: Robot Therapy for Rehabilitation of Hand Movement After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Movement Disorders
Hemiparesis
Keywords: robotic therapy
finger
hand
Lead sponsor: The Catholic University of America
Sponsor class: OTHER
Collaborators: name: MedStar National Rehabilitation Network
First posted: 2020-09-03
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to two study groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fugl-Meyer Test of Motor Function
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Change in Action Research Arm Test
timeFrame: 6 month follow-up
measure: Change in finger extension range of motion (degrees)
timeFrame: 6 month follow-up
measure: Change in Modified Ashworth Test
timeFrame: 6 month follow-up
measure: Change in Motor Activity Log
timeFrame: 6 month follow-up
measure: Change in Grip Strength
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Network
state: District of Columbia
Study officials:
affiliation: The Catholic University of America
name: Peter Lum
role: PRINCIPAL_INVESTIGATOR
References:
citation: Godfrey SB, Holley RJ, Lum PS. Evaluation of HEXORR Tone Assistance Mode Against Spring Assistance. IEEE Trans Neural Syst Rehabil Eng. 2015 Jul;23(4):610-7. doi: 10.1109/TNSRE.2015.2398933. Epub 2015 Feb 4.
citation: Godfrey SB, Holley RJ, Lum PS. Clinical effects of using HEXORR (Hand Exoskeleton Rehabilitation Robot) for movement therapy in stroke rehabilitation. Am J Phys Med Rehabil. 2013 Nov;92(11):947-58. doi: 10.1097/PHM.0b013e31829e7a07.
citation: Schabowsky CN, Godfrey SB, Holley RJ, Lum PS. Development and pilot testing of HEXORR: hand EXOskeleton rehabilitation robot. J Neuroeng Rehabil. 2010 Jul 28;7:36. doi: 10.1186/1743-0003-7-36.