Effects of Visual Biofeedback Therapy in Parkinson's Patients

Study Overview
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Brief Summary
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Parkinson's disease (PD) affects approximately 6.5 million people around the world and it is ranked as the second most common age-related neurodegenerative disease after Alzheimer disease. US have reported 800,000 PD patients in 2016, the highest number of reported PD patients in the world while UK has the lowest number of PD cases i.e. 100,000. With a rise of 2.3 million cases in 2026, an approximate annual growth rate of 2.52% is predicted globally. According to Pakistan Parkinson's society, approximately 450,000 Pakistanis were affected with PD. The age-specific prevalence of PD in Pakistan was found to be high in 70 to 79 years of age with males being more affected as compared to females. Parkinson's disease is a neurological condition, characterized by tremors, rigidity, and stiffness in the body, along with bradykinesia, walking and balance problems. Poor balance is one of the major and most disabling characteristics among Parkinson patients. Freezing of gait (FOG) and postural instability is one of the major cause of fall and loss of independence among PD patients whereas cognitive dysfunction is one of the common non-motor symptoms affecting 20 to 57% of PD patients. Among recent technological advancements in neurological physical therapy, virtual reality (VR) games have become an area of interest for researchers. Despite advances in the rehabilitation of PD, evidence regarding the effects of visual biofeedback therapy on Parkinson patients is still scarce. Only few studies have studied the effects of visual biofeedback therapy on balance in PD patients, but as per knowledge of the researcher there is no study published on effects of visual biofeedback therapy on FOG and cognition among Parkinson patients in Pakistan. Therefore, the present study is aimed to assess the effects of biofeedback balance training using a balance board on balance, FOG and cognition in patients with Parkinson disease.

Detailed Description
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A total number of 36 patients will be recruited in the study. After the voluntary consent, all the patients will be randomly divided into Group A and B through the envelope method of simple random sampling. In addition, a total of 36 sealed envelopes, comprised of 18 envelopes for each group will be presented to the patients. Each patient will be asked to select one envelope of their choice. Upon selection of the envelope, patients will be allocated to the respective group. Thus, each group will comprise 18 patients respectively. Afterward, pre-assessment will be performed for each patient on all three outcome measures i.e. FRT, FOG-Q, and MoCA. A total of 36 patients will be recruited and assigned into two groups. Group A will receive visual biofeedback balance exercises and Group B will receive Conventional balance exercises. The intervention will be given for 8 consecutive weeks to each group. The training session will be based on a warm-up session for 5 to 10 minutes to each group followed by 30 minutes' session of visual biofeedback therapy for group A and 30 minutes balance exercises for group B and a cool-down period of 5 to 10 minutes excluding intervals of 1-minute rest after 5 minutes of activity. A trial will be terminated, if the patient reported ataxia, vertigo and syncope, feeling of fatigue and difficulty during exercise through fatigue severity scale and subjects unwilling to perform exercise.

Official Title
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Effects of Visual Biofeedback Therapy on Balance, Freezing of Gait and Cognition Among Stage III Parkinson's Patients: A Randomized Controlled Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Visual Biofeedback Therapy
* Behavioral: Conventional Balance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parkinson's disease of age between 60-79 years. Diagnosed PD stage III. Exclusion Criteria: Other neurological problems (Multiple sclerosis, amyotrophic lateral sclerosis and myasthenia gravis). Migraine. Auditory or visual deficits. Orthostatic hypotension.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental: Game-Based Rehabilitation: Device: Visual Biofeedback Therapy Session Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks. Placebo Comparator: Conventional Rehabilitation: Conventional Balance exercise Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arms 1<br>Game-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. | Device: Visual Biofeedback Therapy<br>* Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.<br>|
| Placebo Comparator: Arms 2<br>Conventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks. | Behavioral: Conventional Balance exercise<br>* Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance | Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function | Baseline | 
| Balance | Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function | After 8 weeks | 
| Freezing of Gait (FOG) | Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait | Pre-Treatment | 
| Freezing of Gait (FOG) | Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait | After 8 weeks | 
| Cognitive Function | Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function | Pre-Treatment | 
| Cognitive Function | Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function | After 8 weeks |