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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111924
• Other study ID #: REC/0042250 Zunaira Ahmad
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: October 2023
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Task oriented circuit training based telerehabilitation
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 training
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.

Locations

Country	Name	City	State
Pakistan	Sehat Medical Complex	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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 a = 0.80; item-scale correlation efficient: 0.56-0.72).	6th week