Robotic Rehabilitation for Stroke Survivors

Pilot study on the physiological response of robotic rehabilitation therapy for improving the performance of activities of daily living of stroke patients

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Device: Emulation of Active Daily Living tasks with a robotic device (SPINDLE)

Detailed Description

The purpose of this research is to study the feasibility of the robotic therapy that can train activities of daily living tasks for chronic stroke patients. The participant will be involved in a feasibility study (one-time visit) to prove the efficacy of the robotic device with different force feedback (assistive and resistive force) and other feedback such as VR (virtual reality). We will collect movement data from a motion capture system and sEMG sensors that measure muscle activity to monitor the effect of a robotic rehabilitation device, named Spherical Parallel Instrument for Daily Living Emulation (SPINDLE). We will use a robotic therapy device to practice activities during daily living. This pilot study will be used to understand the effect of SPINDLE to translate the device as a home-based training for chronic stroke patients.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jiyeon Kang; Phone Number: 7166456063; Email: jiyeonk@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14260
      • University at Buffalo, North Campus, Furnas 809
      • Contact: Jiyeon Kang; Phone Number: 716-645-6063; Email: jiyeonk@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study participant needs to have minimal strength to move the robot. The participant needs to be able to understand the instructions during the experiment.

Description

Inclusion Criteria:

• Adults with chronic stroke, which affected their upper limb motor functions
• Adults could able to understand the verbal cues during the training

Exclusion Criteria:

• Adults with chronic stroke, who did not lose their upper limb motor functions

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participant with Chronic stroke; Participants over 18 years of age; Participants should be able to understand the verbal cues during the training	Device: Emulation of Active Daily Living tasks with a robotic device (SPINDLE); SPINDLE will provide an assistive and resistive force to aid in rehabilitating the subject's upper limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic change of the upper limb during ADLs	The max and range of motion of shoulder, elbow, and wrist joint for each task	immediately after the intervention
Score of activities of daily living(ADL) tasks	We will use ARM-ULA standard score sheet to measure the performance of ADLs	immediately after the intervention
Muscle activation change of the upper limb during ADLs	The subject will be asked to perform activities of daily living tasks with the passive SPINDLE. Upper limb range of motion and muscle activation will be quantified.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability measure	Questionnaire will be provided to the user to obtain qualitative feedback	immediately after the intervention

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: Department of Neurology Jacobs School of Medicine and Biomedical Sciences University at Buffalo.
• Investigators: Principal Investigator: Jiyeon Kang, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 5, 2024
• Study Completion (Estimated): December 5, 2024

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STUDY00005946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data will be shared upon request to PI.
• IPD Sharing Time Frame: After the study is completed
• IPD Sharing Access Criteria: The personnel who is requesting the data needs to explain how the data will be used in their research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No