NCT04835649

Brief Summary

Parkinson's Disease (PD) is a disease that affects the functional skills of the upper extremity with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily life activities of the patients. Task-oriented training (TOT) is a highly individualized, client-centered, occupational therapy, functional-based intervention compatible with motor learning and motor control principles such as intensive motor training, variable practice, and intermittent feedback. Few studies have been found on the TOT of the upper extremity in PD. Telerehabilitation of Parkinson's patients shows many strengths, such as cost-related and time-dependent ease, and the possibility of telecommunication with clinicians. In addition, the refinement of digital health solutions with the goal to offer a patient-tailored intervention remains an ongoing process. There are a limited number of studies on TOT and telerehabilitation of the upper extremity in PD. In addition, no studies have been found applying TOT through telerehabilitation. For this purpose, a study including TOT-based telerehabilitation in upper extremity education in PD was planned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

March 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

March 30, 2021

Last Update Submit

May 25, 2022

Conditions

Keywords

Parkinson DiseaseTelerehabilitationTask-orientedupper extremity

Outcome Measures

Primary Outcomes (6)

  • Manual dexterity performance - Baseline

    Nine Hole Peg test (9-HPT)

    Assessment will be conducted before the intervention

  • Manual dexterity performance - Post intervention

    Nine Hole Peg test (9-HPT)

    Assessment will be conducted immediately after the intervention

  • Finger and hand function - Baseline

    Jebsen-Taylor Hand Function Test (JTHFT)

    Assessment will be conducted before the intervention

  • Finger and hand function - Post intervention

    Jebsen-Taylor Hand Function Test (JTHFT)

    Assessment will be conducted immediately after the intervention

  • Upper extremity performance (coordination, dexterity and functioning) - Baseline

    Action Research Arm Test (ARAT)

    Assessment will be conducted before the intervention

  • Upper extremity performance (coordination, dexterity and functioning) - Post intervention

    Action Research Arm Test (ARAT)

    Assessment will be conducted immediately after the intervention

Secondary Outcomes (8)

  • Isometric hand strength - Baseline

    Assessment will be conducted before the intervention

  • Isometric hand strength - Post intervention

    Assessment will be conducted immediately after the intervention

  • Isometric pinch strength - Baseline

    Assessment will be conducted before the intervention

  • Isometric pinch strength - Post intervention

    Assessment will be conducted immediately after the intervention

  • Disease severity and disability - Baseline

    Assessment will be conducted before the intervention

  • +3 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

The group that will receive task-oriented training via telerehabilitation

Other: Exercise

Control group

PLACEBO COMPARATOR

The control group only will be given a home program that includes walking and balance exercises

Other: Exercise

Interventions

Both groups will receive exercise-based training

Control groupExercise group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Having diagnosed with "Parkinson's Disease" by a specialist physician
  • Having between 1-3 stages according to the Hoehn and Yahr Scale
  • Mini-Mental Test score more than or equal 24

You may not qualify if:

  • \- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sefa Eldemir, PT, MSc.

    Research Assistant

    STUDY CHAIR
  • Arzu Güçlü-Gündüz, PT, PhD.

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups as exercise group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 8, 2021

Study Start

April 15, 2021

Primary Completion

May 15, 2022

Study Completion

May 25, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.

Locations