NCT06246747

Brief Summary

The goal of this pilot randomized clinical trial was to assess the feasibility of telerehabilitation (TR) for patients with Parkinson\'s Disease (PD). The main questions it aims to answer are: 1. whether the recruitment to such a study will be successful and the satisfaction of both participants and clinicians will be good. 2. Clinical effectiveness of TR for patients with PD was also explored. Participants were randomized to 3 groups : 1. Clinic+TR. 2. TR-only group and 3. A usual control group. Results were compared between the groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
Last Updated

March 15, 2024

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

December 14, 2023

Last Update Submit

March 12, 2024

Conditions

Keywords

Parkinson Diseasephysical therapytelerehabilitationsatisfactionadherence to home exercise

Outcome Measures

Primary Outcomes (1)

  • Satisfaction assessment

    We assessed satisfaction with the mode of care delivery using novel surveys, which were administered to the patient and the physical therapist at the in-clinic discharge visit via the Research Electronic Data Captureapture (REDCap) platform. Each survey assessed eight constructs; six satisfaction items were rated on a 5-point Likert scale ("very poor", "poor", "fair", "good", or "very good"). The number 1 stood for "very poor" and the number 5 stood for "very good". The item pertaining to safety asked for a 0 ("very unsafe") to 100 ("very safe") rating.

    From enrollment to end of treatment at 5 weeks

Secondary Outcomes (1)

  • Clinical effectiveness of TR

    From enrollment to end of treatment at 5 weeks

Study Arms (3)

Physical therapy treatment in the clinic + telerehabilitation

EXPERIMENTAL

Patients performed treatments in the clinic in the presence of their physical therapist (PT) as well as perform remote treatment from their homes. The remote treatment included using video chat with their PT as well as performing PD-specific exercises which were stored in a specific library on the platform.

Other: In clinic physical therapyOther: Telerehabilitation only

TR-only

EXPERIMENTAL

Patients received treatment at their homes using the TR platform. This included video chat with their clinician as well as performing PD-specific exercises which were stored in a specific library on the platform.

Other: Telerehabilitation only

Control group

ACTIVE COMPARATOR

Patients received treatment in the clinic in the presence of their PT

Other: In clinic physical therapy

Interventions

Patients visit the clinic to receive traditional physical therapy treatment

Control groupPhysical therapy treatment in the clinic + telerehabilitation

Patients receive remote treatment using the Wizecare platform

Also known as: Wizecare Telerehabilitation Platform
Physical therapy treatment in the clinic + telerehabilitationTR-only

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient older than 18 with PD of any duration
  • The patient was scheduled for a new episode of physical therapy.

You may not qualify if:

  • Any outpatient physical therapy episode in the preceding 5 months
  • Documented diagnosis of another progressive neurological disease
  • History of epilepsy
  • Moderate to severe cognitive impairment
  • Hemiparesis or hemiplegia
  • Current complaints of dizziness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleavelnad Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (38)

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    PMID: 15679464BACKGROUND
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    PMID: 22210979BACKGROUND
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    PMID: 33123423BACKGROUND
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MeSH Terms

Conditions

Parkinson DiseasePersonal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mary Stilphen, PT, DPT

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

February 7, 2024

Study Start

February 1, 2020

Primary Completion

January 23, 2023

Study Completion

January 23, 2023

Last Updated

March 15, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations