Effects of Visual Biofeedback Therapy in Parkinson's Patients

NCT ID: NCT05325541

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-15

Brief Summary

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

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arms 1

Game-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.

Group Type: EXPERIMENTAL

Visual Biofeedback Therapy

Intervention Type: DEVICE

Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.

Arms 2

Conventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.

Group Type: PLACEBO_COMPARATOR

Conventional Balance exercise

Intervention Type: BEHAVIORAL

Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.

Interventions

Visual Biofeedback Therapy

Visual Biofeedback intervention will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fouzia Hussain, MPhil

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University Karachi, Sindh, Pakistan

Locations

Ziauddin University

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Fouzia Hussain, MPhil

Role: CONTACT

fouziaphysio@gmail.com

021-36629251 ext. 5

Facility Contacts

Fouzia Hussain, MPhil

Role: primary

fouziaphysio@gmail.com

021-36629251 ext. 5

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Other Identifiers

4471121FHREH

Identifier Type: -

Identifier Source: org_study_id