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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111924

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Task oriented circuit training based telerehabilitation Other: Clinic based Task oriented circuit training	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Task oriented circuit training based telerehabilitation (TOCT-TR) group 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 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.
Experimental: Clinic based Task oriented circuit training (TOCT-CR) group 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 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.

Arm

Intervention/Treatment

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

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

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.

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

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

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.

Outcome Measures

Primary Outcome Measures

Hoehn-Yahr Classification of Disability Scale [6th week]
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.
Jebsen Taylor Hand Function test [6th week]
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)
Box and Block Test [6th week]
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)
Parkinson's Disease Questionnaire (PDQ-8) [6th week]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).