NCT07457710

Brief Summary

Individuals with Parkinson's Disease (PD) often have motor difficulties that can negatively impact daily activities and their quality of life. Research has shown that to slow the progression of these symptoms, patients should partake in effective physical rehabilitation. However, effective physical rehabilitation has many barriers, including timing, cost, and other personal or system-level challenges. The purpose of this study is to evaluate the haptic remote rehabilitation system for patients with PD using a randomized controlled trial (RCT) in a field environment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Mar 2026Jun 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

February 26, 2026

Last Update Submit

June 3, 2026

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's DiseaseHapticRemote Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • System Usability Scale (SUS)

    This scale evaluates participants' perceived usability of the device and the haptic feedback. It consists of 10 items, each scored on a 5-point Likert scale (0-4). The total raw score is converted to a scale of 0-100. A higher score will indicate better usability. A score of 68 is considered average usability. Scores above 68 reflect above average usability, while scores below 68 reflect below-average usability.

    At the end of the trial in week 8

  • Arm movement accuracy, speed, and smoothness

    Each handheld device (both with and without haptic) are equipped with Intertial Measurement Units (IMUs). The data from the IMUs will be used to measure the movement accuracy, speed, and smoothness of the arm. Data recording will start during enrollment as baseline. Whenever participants complete any sessions during the 8-week trial period, data from the IMUs will be recorded to calculate movement accuracy, speed, and smoothness. We will compare these measures across the trial period to determine performance changes in the participants.

    From enrollment to the end of intervention at 8 weeks

Secondary Outcomes (3)

  • Outcome Expectations of Exercise Scale (OEES)

    At the end of the trial in week 8

  • Self-Efficacy Scale (SES)

    At the end of the trial in week 8

  • Parkinson's Disease Questionnaire (PDQ-8)

    At baseline (Week 0)

Study Arms (2)

Haptic group

EXPERIMENTAL

Participants will receive a handheld device that can provide haptic feedback to guide them in performing different movement tasks. Each participant will be asked to participate in sessions lasting up to one hour, twice/week, for an 8-week period. Participants will be asked to perform typical upper-body movement tasks performed in rehabilitation sessions based on their functional capabilities. This includes "Full Extension Circles", "Shoulder Press", "Full Lateral Movement", and "Random Target Matching" activity. The haptic device will provide directional guidance to support the participants in completing these movement tasks.

Device: Haptic device

Non-haptic group

SHAM COMPARATOR

Participants will receive a handheld device similar to the haptic group. However, this device will not provide any haptic feedback. Each participant will be asked to participate in sessions lasting up to one hour, twice/week, for an 8-week period. Participants will be asked to perform typical upper-body movement tasks performed in rehabilitation sessions based on their functional capabilities. This includes "Full Extension Circles", "Shoulder Press", "Full Lateral Movement", and "Random Target Matching" activity. Participants will be asked to hold the handheld device during the tasks; however, they will not receive any haptic feedback from the device.

Device: Non-haptic device

Interventions

Haptic deviceDEVICE

Participants will receive a custom-made handheld haptic device, which will be used to perform selected movement tasks. The device can generate the feeling of directional feedback.

Haptic group
Non-haptic deviceDEVICE

Participants will receive a handheld device similar to the haptic group. However, the device in this intervention will not provide any haptic feedback.

Non-haptic group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old
  • Diagnosed with PD

You may not qualify if:

  • Hoehn and Yahr stage outside 1-3
  • Lives outside the 48 contiguous states in the USA
  • Unable to move hands and head without assistance
  • Unable to remain seated in an upright position for up to an hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24060, United States

RECRUITING

Related Publications (8)

  • Garzo, A., Jung, J. H., Arcas-Ruiz-Ruano, J., Perry, J. C., & Keller, T. (2022). ArmAssist: A telerehabilitation solution for upper-limb rehabilitation at home. IEEE Robotics & Automation Magazine, 30(1), 62-71.

    BACKGROUND

  • Dockx K, Bekkers EM, Van den Bergh V, Ginis P, Rochester L, Hausdorff JM, Mirelman A, Nieuwboer A. Virtual reality for rehabilitation in Parkinson's disease. Cochrane Database Syst Rev. 2016 Dec 21;12(12):CD010760. doi: 10.1002/14651858.CD010760.pub2.

    PMID: 28000926BACKGROUND

  • Langer A, Gassner L, Flotz A, Hasenauer S, Gruber J, Wizany L, Pokan R, Maetzler W, Zach H. How COVID-19 will boost remote exercise-based treatment in Parkinson's disease: a narrative review. NPJ Parkinsons Dis. 2021 Mar 8;7(1):25. doi: 10.1038/s41531-021-00160-3.

    PMID: 33686074BACKGROUND

  • Zaman MS, Ghahari S, McColl MA. Barriers to Accessing Healthcare Services for People with Parkinson's Disease: A Scoping Review. J Parkinsons Dis. 2021;11(4):1537-1553. doi: 10.3233/JPD-212735.

    PMID: 34308913BACKGROUND

  • Xia R, Mao ZH. Progression of motor symptoms in Parkinson's disease. Neurosci Bull. 2012 Feb;28(1):39-48. doi: 10.1007/s12264-012-1050-z.

    PMID: 22233888BACKGROUND

  • Marras C, Beck JC, Bower JH, Roberts E, Ritz B, Ross GW, Abbott RD, Savica R, Van Den Eeden SK, Willis AW, Tanner CM; Parkinson's Foundation P4 Group. Prevalence of Parkinson's disease across North America. NPJ Parkinsons Dis. 2018 Jul 10;4:21. doi: 10.1038/s41531-018-0058-0. eCollection 2018.

    PMID: 30003140BACKGROUND

  • GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.

    PMID: 30287051BACKGROUND

  • Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.

    PMID: 28150045BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sol Lim, Ph.D.

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sol Lim, Ph.D.

CONTACT

540-231-0083sol@vt.edu

Shafiqul Islam, Ph.D.

CONTACT

520-244-9680shafiqul@vt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blindly assigned to one of the groups to reduce bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In this study, the investigator will randomly assign participants to either the haptic group (intervention) or the non-haptic group (sham comparator). Both participants will receive a similar handheld device and will perform selected exercise tasks. The haptic (intervention) group will receive haptic feedback through the device. The non-haptic (sham comparator) group will not receive any haptic feedback. However, both devices will be identical in nature. Participants will remain in their assigned group throughout the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor at the Grado Department of Industrial and Systems Engineering

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 9, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)