Robotic Rehabilitation for Stroke Survivors

Chronic Stroke Clinical Trial

Official title:

Robotic Rehabilitation for Stroke Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05417828
• Other study ID #: STUDY00005946
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 5, 2024

Study information

• Verified date: December 2023
• Source: State University of New York at Buffalo
• Contact: Jiyeon Kang
• Phone: 7166456063
• Email: jiyeonk[@]buffalo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 5, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	University at Buffalo, North Campus, Furnas 809	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Department of Neurology Jacobs School of Medicine and Biomedical Sciences University at Buffalo.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Usability measure	Questionnaire will be provided to the user to obtain qualitative feedback	immediately after the intervention