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Parkinson DiseaseNCT06111924

Effects of Telerehabilitation Versus Clinic-based Task-oriented Circuit Training in Parkinson's Patients

A study testing Task oriented circuit training based telerehabilitation and Clinic based Task oriented circuit training in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized clinical trial aims to determine effects of Telerehabilitation versus clinic-based task-oriented circuit training on upper extremity functions and quality of life in Parkinson's patient. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Parkinson Disease
What is being tested?
Task oriented circuit training based telerehabilitation and Clinic based Task oriented circuit training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePakistan
Study dates
1 Sep 2023to 1 Feb 2024
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age group of 40-70 years.
  • Both gender male and female.
  • Diagnosed cases of Parkinson's disease
  • Stage 1 and 2 Parkinson's according to Hoehn-Yahr Classification of Disability Scale
  • Cognitive stability as defined by a mini-mental state examination (MMSE) score >24.
  • Availability of technical instruments for video-call (tablet, laptop, or computer/webcam) and ability to use them by patients and/or caregiver.
  • Availability and motivation of patients to participate to a 6-weeks telerehabilitation program

Who cannot join

  • Visual loss
  • Hearing loss
  • Any musculoskeletal disorder in which exercises are contraindicated. (Trauma, fracture, dislocation or subluxation etc.)
  • Secondary neurological, orthopedic, or systemic disorders preventing independent standing and walking.
  • Severe peripheral vestibular dysfunction
  • Co-morbidity with non-stabilized major medical illnesses.
  • Presence of freezing of gait (FOG).

Trial locations and contacts

1 site in 1 country.

Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Sehat Medical Complex

    Lahore, Punjab Province, 55201

    Arnab Altaf, 0306 4585776, arnab.altaf@riphah.edu.pk

    Zunaira Ahmad, MSNMPT

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Telerehabilitation Versus Clinic-based Task-oriented Circuit Training on Upper Extremity Functions and Quality of Life in Parkinson's Patient.

This randomized clinical trial aims to determine effects of Telerehabilitation versus clinic-based task-oriented circuit training on upper extremity functions and quality of life in Parkinson's patient.

Read the detailed description

Parkinson's disease is a neurodegenerative disorder that primarily affects the motor system. It is also affecting dexterity of upper limb. Working on its rehabilitation is important question these days. There is growing evidence that intensity and task-specificity of practice delivered by physical- (PT) may be effective and compliment to pharmacological and surgical treatments. Notably, task specific training improves the patient's abilities in ADL and increases levels of participation. This study aims to compare the effects of telerehabilitation and clinic-based task-oriented circuit training on upper extremity functions and quality of life in Parkinson's patients. Telerehabilitation offers increased accessibility, personalized care, and continuity of therapy. It provides therapy in a convenient way and allows for remote monitoring and feedback.

This randomized clinical trial will be conducted at Lahore general hospital and Sehat Medical complex, Lahore. Diagnosed cases of Parkinson's disease falling in Stage 1 and 2 according to Hoehn-Yahr Classification of Disability Scale with Cognition level according to mini-mental state examination (MMSE) score >24 will be included. Sample will be selected by non-probability convenient sampling technique. Patients will be enrolled and assessed for eligibility criteria. Randomization will be done by sealed envelope method and allocated into two groups, one will get telerehabilitation based task-oriented circuit training TOCT-TR and other group will receive clinic-based task-oriented circuit training TOCT-CR. Patients will be blinded about intervention group. Interventions will be applied for 6 weeks. Pre and post treatment assessment will be done by assessor blinded to study. Thus, it will be double blinded study. Analysis will be done by SPSS 29 version. The findings can contribute to the growing evidence base supporting the use of telerehabilitation in Parkinson's disease management and guide future rehabilitation practices.

Being tested
Task oriented circuit training based telerehabilitation, Clinic based Task oriented circuit training
Keywords
Parkinson's disease, Quality of Life, Telerehabilitation, Task oriented circuit training, Upper limb dysfunction
Medical subject headings
Parkinson Disease

What participants receive

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

  • Task oriented circuit training based telerehabilitationOther

    Task oriented circuit training based telerehabilitation (TOCT-TR) via video conference call will be provided for 6 weeks, thrice a week in total18 sessions. Total 15 exercises will be performed by patient in a session of 60 minutes. Duration per exercise will be 3 minutes and a rest interval of 1 will be provided after each exercise.

  • Clinic based Task oriented circuit trainingOther

    Clinic based Task oriented circuit training (TOCT-CR) will be provided in clinic as in person training for 6 weeks, thrice a week in total18 sessions. Total 15 exercises will be performed by patient in a session of 60 minutes. Duration per exercise will be 3 minutes and a rest interval of 1 will be provided after each exercise.

Study groups in NCT06111924
Study groupRoleWhat they receive
Task oriented circuit training based telerehabilitation (TOCT-TR) groupExperimentalThis group will recieve Task oriented circuit training based telerehabilitation (TOCT-TR) via video conference call in 18 sessions.
Receives: Other: Task oriented circuit training based telerehabilitation
Clinic based Task oriented circuit training (TOCT-CR) groupExperimentalThis group will recieve In person treatment at clinical setting that will be Task oriented circuit training based telerehabilitation in 18 sessions.
Receives: Other: Clinic based Task oriented circuit training

What is being measured

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

  1. Hoehn-Yahr Classification of Disability Scale

    Change from baseline. (For classification of disability) The Hoehn and Yahr Scale is used to measure how Parkinson's symptoms progress and the level of disability. It included stages 1 to 5. Stage 1 defines, Unilateral involvement only usually with minimal or no functional disability and stage include Bilateral or midline involvement without impairment of balance. Patients with these 2 stages will be included in study.

    Measured: 6th week

  2. Jebsen Taylor Hand Function test

    Change from baseline. (For upper limb function dexterity) The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects. Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance. JTHFT had moderate to high test-retest reliability and excellent intra rater reliability (r=0.84 and 0.85, P<0.05)

    Measured: 6th week

  3. Box and Block Test

    Change from baseline. (For manual dexterity) The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. Excellent test-retest reliability of the right hand for subjects with impairment (ICC= 0.90) and of the left hand for subjects with impairment (ICC= 0.89)

    Measured: 6th week

  4. Parkinson's Disease Questionnaire (PDQ-8)

    Change from baseline. (For Quality of life) The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It was developed to reduce the respondent burden and increase convenience for use among persons with Parkinson's Disease in clinical settings. PDQ-8 was constructed by taking one question from each domain of PDQ-39. To assess quality of life. The PDQ-8 has acceptable internal consistency (Cronbach's α = 0.80; item-scale correlation efficient: 0.56-0.72).

    Measured: 6th week

Timeline

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

  1. First posted1 Nov 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06111924
Sponsor's protocol ID
REC/0042250 Zunaira Ahmad
Status last verified
Oct 2023
First submitted
26 Oct 2023
Last updated
1 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.

    PubMed 33848468
  • Salmon R, Preston E, Mahendran N, Ada L, Flynn A. People with mild Parkinson's disease have impaired force production in upper limb muscles: A cross-sectional study. Physiother Res Int. 2023 Jan;28(1):e1976. doi: 10.1002/pri.1976. Epub 2022 Oct 20.

    PubMed 36266769
  • Varalta V, Evangelista E, Righetti A, Morone G, Tamburin S, Picelli A, Fonte C, Tinazzi M, Di Vico IA, Waldner A, Filippetti M, Smania N. Effect of Upper Limb Motor Rehabilitation on Cognition in Parkinson's Disease: An Observational Study. Brain Sci. 2022 Dec 8;12(12):1684. doi: 10.3390/brainsci12121684.

    PubMed 36552144
  • Soke F, Guclu-Gunduz A, Kocer B, Fidan I, Keskinoglu P. Task-oriented circuit training combined with aerobic training improves motor performance and balance in people with Parkinson's Disease. Acta Neurol Belg. 2021 Apr;121(2):535-543. doi: 10.1007/s13760-019-01247-8. Epub 2019 Nov 18.

    PubMed 31741209
  • Vanbellingen T, Nyffeler T, Nigg J, Janssens J, Hoppe J, Nef T, Muri RM, van Wegen EEH, Kwakkel G, Bohlhalter S. Home based training for dexterity in Parkinson's disease: A randomized controlled trial. Parkinsonism Relat Disord. 2017 Aug;41:92-98. doi: 10.1016/j.parkreldis.2017.05.021. Epub 2017 May 25.

    PubMed 28578819
  • Bianchini E, Onelli C, Morabito C, Alborghetti M, Rinaldi D, Anibaldi P, Marcolongo A, Salvetti M, Pontieri FE. Feasibility, Safety, and Effectiveness of Telerehabilitation in Mild-to-Moderate Parkinson's Disease. Front Neurol. 2022 Jun 16;13:909197. doi: 10.3389/fneur.2022.909197. eCollection 2022.

    PubMed 35785358
  • 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.

    PubMed 36917914
  • Zare M, Ozdemir H, Tavsan MY, Tuna F, Sut N, Guler S, Kabayel DD. Effect of activity-based training versus strengthening exercises on upper extremity functions in Parkinson's patients; A randomized controlled, single blind, superiority trial. Clin Neurol Neurosurg. 2022 Jul;218:107261. doi: 10.1016/j.clineuro.2022.107261. Epub 2022 Apr 29.

    PubMed 35567829
  • Voola SI, Hema S. Effectiveness of tele rehabilitation on manual dexterity and its impact on quality of life in patients with Parkinson's disease: A pilot study. Indian Journal of Physiotherapy & Occupational Therapy Print-(ISSN 0973-5666) and Electronic-(ISSN 0973-5674). 2020;14(2):186-93.

  • Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial. NeuroRehabilitation. 2020;46(3):343-353. doi: 10.3233/NRE-203029.

    PubMed 32310197
  • Cikajlo I, Hukic A, Dolinsek I, Zajc D, Vesel M, Krizmanic T, Blazica B, Biasizzo A, Novak F, Peterlin Potisk K. Can telerehabilitation games lead to functional improvement of upper extremities in individuals with Parkinson's disease? Int J Rehabil Res. 2018 Sep;41(3):230-238. doi: 10.1097/MRR.0000000000000291.

    PubMed 29757774
  • Foki T, Vanbellingen T, Lungu C, Pirker W, Bohlhalter S, Nyffeler T, Kraemmer J, Haubenberger D, Fischmeister FP, Auff E, Hallett M, Beisteiner R. Limb-kinetic apraxia affects activities of daily living in Parkinson's disease: a multi-center study. Eur J Neurol. 2016 Aug;23(8):1301-7. doi: 10.1111/ene.13021. Epub 2016 May 1.

    PubMed 27132653
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343
  • Kasten M, Bruggemann N, Schmidt A, Klein C. Validity of the MoCA and MMSE in the detection of MCI and dementia in Parkinson disease. Neurology. 2010 Aug 3;75(5):478; author reply 478-9. doi: 10.1212/WNL.0b013e3181e7948a. No abstract available.

    PubMed 20679642
  • Modestino EJ, Reinhofer A, Blum K, Amenechi C, O'Toole P. Hoehn and Yahr staging of Parkinson's disease in relation to neuropsychological measures. Front Biosci (Landmark Ed). 2018 Mar 1;23(7):1370-1379. doi: 10.2741/4649.

    PubMed 29293439

Questions about this trial

What is this clinical trial studying?

A study testing Task oriented circuit training based telerehabilitation and Clinic based Task oriented circuit training in people with Parkinson Disease, run by Riphah International University at 1 site in Pakistan.

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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. 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 Pakistan. 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. 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?

Results are not available in the source record.

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

Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hoehn-Yahr Classification of Disability Scale (time frame: 6th week). The study lists 4 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 NCT06111924, which also lists 15 linked publications.

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 1 Nov 2023.

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