NCT05417828

Brief Summary

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

June 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
3.5 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

June 5, 2022

Last Update Submit

March 20, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Usability measure

    immediately after the intervention

Study Arms (1)

Participant with Chronic stroke

1. Participants over 18 years of age 2. Participants should be able to understand the verbal cues during the training

Device: Emulation of Active Daily Living tasks with a robotic device (SPINDLE)

Interventions

SPINDLE will provide an assistive and resistive force to aid in rehabilitating the subject's upper limb

Participant with Chronic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo, North Campus, Furnas 809

Buffalo, New York, 14260, United States

Location

Study Officials

  • Jiyeon Kang

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 14, 2022

Study Start

December 1, 2025

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

December 5, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

The de-identified data will be shared upon request to PI.

Time Frame
After the study is completed
Access Criteria
The personnel who is requesting the data needs to explain how the data will be used in their research.

Locations