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Robotic Rehabilitation for Stroke Survivors

Primary Purpose

Chronic Stroke

Status
Not yet recruiting
Phase
Locations
United States
Study Type
Observational
Intervention
Emulation of Active Daily Living tasks with a robotic device (SPINDLE)
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Chronic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University at Buffalo, North Campus, Furnas 809

Arms of the Study

Arm 1

Arm Type

Arm Label

Participant with Chronic stroke

Arm Description

Participants over 18 years of age Participants should be able to understand the verbal cues during the training

Outcomes

Primary Outcome Measures

Kinematic change of the upper limb during ADLs
The max and range of motion of shoulder, elbow, and wrist joint for each task
Score of activities of daily living(ADL) tasks
We will use ARM-ULA standard score sheet to measure the performance of ADLs
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.

Secondary Outcome Measures

Usability measure
Questionnaire will be provided to the user to obtain qualitative feedback

Full Information

First Posted
June 5, 2022
Last Updated
August 27, 2023
Sponsor
State University of New York at Buffalo
Collaborators
Department of Neurology Jacobs School of Medicine and Biomedical Sciences University at Buffalo.
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1. Study Identification

Unique Protocol Identification Number
NCT05417828
Brief Title
Robotic Rehabilitation for Stroke Survivors
Official Title
Robotic Rehabilitation for Stroke Survivors
Study Type
Observational

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 5, 2024 (Anticipated)
Study Completion Date
December 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
Department of Neurology Jacobs School of Medicine and Biomedical Sciences University at Buffalo.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participant with Chronic stroke
Arm Description
Participants over 18 years of age Participants should be able to understand the verbal cues during the training
Intervention Type
Device
Intervention Name(s)
Emulation of Active Daily Living tasks with a robotic device (SPINDLE)
Intervention Description
SPINDLE will provide an assistive and resistive force to aid in rehabilitating the subject's upper limb
Primary Outcome Measure Information:
Title
Kinematic change of the upper limb during ADLs
Description
The max and range of motion of shoulder, elbow, and wrist joint for each task
Time Frame
immediately after the intervention
Title
Score of activities of daily living(ADL) tasks
Description
We will use ARM-ULA standard score sheet to measure the performance of ADLs
Time Frame
immediately after the intervention
Title
Muscle activation change of the upper limb during ADLs
Description
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.
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Usability measure
Description
Questionnaire will be provided to the user to obtain qualitative feedback
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
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.
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyeon Kang
Phone
7166456063
Email
jiyeonk@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyeon Kang
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo, North Campus, Furnas 809
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyeon Kang
Phone
716-645-6063
Email
jiyeonk@buffalo.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Robotic Rehabilitation for Stroke Survivors

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