AzTrials
AzTrials

Parkinson DiseaseNCT04835649

The Effectiveness of Telerehabilitation in Improving Upper Extremity in Parkinson's Patients

A study testing Exercise in people with Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
Parkinson Disease
What is being tested?
Exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Apr 2021to 25 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 45- 70 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of Task-Oriented Training Based Telerehabilitation in Improving Upper Extremity Motor Function in Parkinson's Patients

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.

Read the detailed description

This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. In addition, the exercise group will receive TOT-based telerehabilitation via video conferencing 3 days a week for 6 weeks. TOT will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. As the outcome measures, disease severity and disability, finger and hand function, hand strength, and quality of life will be evaluated.

Being tested
Exercise
Keywords
Parkinson Disease, Telerehabilitation, Task-oriented, upper extremity
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Both groups will receive exercise-based training

Study groups in NCT04835649
Study groupRoleWhat they receive
Exercise groupExperimentalThe group that will receive task-oriented training via telerehabilitation
Receives: Other: Exercise
Control groupPlacebo comparatorThe control group only will be given a home program that includes walking and balance exercises
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manual dexterity performance - Baseline

    Nine Hole Peg test (9-HPT)

    Measured: Assessment will be conducted before the intervention

  2. Manual dexterity performance - Post intervention

    Nine Hole Peg test (9-HPT)

    Measured: Assessment will be conducted immediately after the intervention

  3. Finger and hand function - Baseline

    Jebsen-Taylor Hand Function Test (JTHFT)

    Measured: Assessment will be conducted before the intervention

  4. Finger and hand function - Post intervention

    Jebsen-Taylor Hand Function Test (JTHFT)

    Measured: Assessment will be conducted immediately after the intervention

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

    Action Research Arm Test (ARAT)

    Measured: Assessment will be conducted before the intervention

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

    Action Research Arm Test (ARAT)

    Measured: Assessment will be conducted immediately after the intervention

Secondary outcomes (8)

  1. Isometric hand strength - Baseline

    J-Tech ™

    Measured: Assessment will be conducted before the intervention

  2. Isometric hand strength - Post intervention

    J-Tech ™

    Measured: Assessment will be conducted immediately after the intervention

  3. Isometric pinch strength - Baseline

    Baseline® pinch meter

    Measured: Assessment will be conducted before the intervention

  4. Isometric pinch strength - Post intervention

    Baseline® pinch meter

    Measured: Assessment will be conducted immediately after the intervention

  5. Disease severity and disability - Baseline

    MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS has a maximum score of 272 and is composed of four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications) (UPDRS). (0= best , 272= worst)

    Measured: Assessment will be conducted before the intervention

  6. Disease severity and disability - Post intervention

    MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS has a maximum score of 272 and is composed of four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications) (UPDRS). (0= best , 272= worst)

    Measured: Assessment will be conducted immediately after the intervention

  7. Health-related Quality of Life - Baseline

    Parkinson's Disease Questionnaire 8 (PDQ-8). There are 8 questions in total and each question is scored from 0-4 points. High score indicates decreased quality of life

    Measured: Assessment will be conducted before the intervention

  8. Health-related Quality of Life - Post intervention

    Parkinson's Disease Questionnaire 8 (PDQ-8). There are 8 questions in total and each question is scored from 0-4 points. High score indicates decreased quality of life

    Measured: Assessment will be conducted immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start15 Apr 2021
  3. Primary completion15 May 2022
  4. Study completion25 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups as exercise group and control group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04835649
Sponsor's protocol ID
1- PD- UE-Telerehabilitation
Status last verified
May 2022
First submitted
30 Mar 2021
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Parkinson Disease, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Manual dexterity performance - Baseline (time frame: Assessment will be conducted before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04835649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in