NCT05971784

Brief Summary

Parkinson's Disease (PD) is a disease that affects the upper extremity functional skills with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily living activities of the patients. The influence of fine dexterity, reaching, and grasping movements greatly affects the daily living activities of the patients. Medical treatment and surgical approaches are frequently used among the treatment options for PD today. Physiotherapy and rehabilitation approaches for progressive functional loss in PD, together with optimal medical and surgical treatment, form the basis of PD treatment. Recently, it has been stated that intensive and task-specific rehabilitation interventions in the field of physiotherapy and rehabilitation will be more effective than traditional rehabilitation approaches. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enables the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement a task-oriented training (TOT) program based on motor learning-based principles, which consists of intense exercise content, through telerehabilitation. Although there are very few studies investigating the effectiveness of telerehabilitation-based TOT in PD, these studies have shown that upper extremity motor performance, activities of daily living, and quality of life are improved. On the other hand, no study has been found showing the effect of upper extremity TOT applied through telerehabilitation on balance and walking. Therefore, there is a need to investigate the effectiveness of telerehabilitation-based TOT exercises on balance and walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

July 25, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 25, 2023

Last Update Submit

July 25, 2024

Conditions

Keywords

Parkinson diseaseTask oriented trainingBalanceGait

Outcome Measures

Primary Outcomes (6)

  • Static Balance- Baseline

    Assessment will be made with a Biodex Balance System

    Assessment will be conducted before the intervention

  • Static Balance- Post intervention

    Assessment will be made with a Biodex Balance System

    Assessment will be conducted immediately after the intervention

  • Gait- Baseline

    Assessment will be made with the Time up and Go Test

    Assessment will be conducted before the intervention

  • Gait- Post intervention

    Assessment will be made with the Time up and Go Test

    Assessment will be conducted immediately after the intervention

  • Balance- Baseline

    Assessment will be made with the Berg Balance Scale

    Assessment will be conducted before the intervention

  • Balance- Post intervention

    Assessment will be made with the Berg Balance Scale

    Assessment will be conducted immediately after the intervention

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

In addition to the exercise program consisting of balance and walking activities, the group will receive task-oriented upper extremity training via telerehabilitation accompanied by a physiotherapist.

Other: Telerehabilitation Group

Control group

EXPERIMENTAL

The group that will receive a home exercise program consisting of only balance and walking activities

Other: Control Group

Interventions

The group that will receive upper extremity training via telerehabilitation in addition to an exercise program consisting of balance and walking activities

Telerehabilitation group

The group that will receive an exercise program consisting of balance and walking activities

Control group

Eligibility Criteria

Age40 Years - 80 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)

Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Sivas, Turkey (Türkiye)

Location

Related Publications (1)

  • Eldemir S, Guclu-Gunduz A, Eldemir K, Saygili F, Yilmaz R, Akbostanci MC. The effect of task-oriented circuit training-based telerehabilitation on upper extremity motor functions in patients with Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2023 Apr;109:105334. doi: 10.1016/j.parkreldis.2023.105334. Epub 2023 Feb 28.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

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

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

July 25, 2023

Primary Completion

May 10, 2024

Study Completion

June 10, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share data but when the statistical analysis of all data is made, all results will be shared.

Locations