NCT06111924

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

Parkinson's diseaseQuality of LifeTelerehabilitationTask oriented circuit trainingUpper limb dysfunction

Outcome Measures

Primary Outcomes (4)

  • 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.

    6th week

  • 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)

    6th week

  • 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)

    6th week

  • 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).

    6th week

Study Arms (2)

Task oriented circuit training based telerehabilitation (TOCT-TR) group

EXPERIMENTAL

This group will recieve Task oriented circuit training based telerehabilitation (TOCT-TR) via video conference call in 18 sessions.

Other: Task oriented circuit training based telerehabilitation

Clinic based Task oriented circuit training (TOCT-CR) group

EXPERIMENTAL

This group will recieve In person treatment at clinical setting that will be Task oriented circuit training based telerehabilitation in 18 sessions.

Other: Clinic based Task oriented circuit training

Interventions

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.

Task oriented circuit training based telerehabilitation (TOCT-TR) group

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.

Clinic based Task oriented circuit training (TOCT-CR) group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex

Lahore, Punjab Province, 55201, Pakistan

RECRUITING

Related Publications (15)

  • 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.

    PMID: 33848468BACKGROUND
  • 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.

    PMID: 36266769BACKGROUND
  • 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.

    PMID: 36552144BACKGROUND
  • 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.

    PMID: 31741209BACKGROUND
  • 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.

    PMID: 28578819BACKGROUND
  • 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.

    PMID: 35785358BACKGROUND
  • 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.

    PMID: 36917914BACKGROUND
  • 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.

    PMID: 35567829BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32310197BACKGROUND
  • 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.

    PMID: 29757774BACKGROUND
  • 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.

    PMID: 27132653BACKGROUND
  • 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.

    PMID: 17695343BACKGROUND
  • 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.

    PMID: 20679642BACKGROUND
  • 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.

    PMID: 29293439BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Arnab Altaf

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

September 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations