Effects of Visual Biofeedback Therapy in Parkinson's Patients

April 12, 2022 updated by: Ziauddin University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Recruiting
        • Ziauddin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arms 1
Game-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.
Device: 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.
Placebo Comparator: Arms 2
Conventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Baseline
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
Time Frame: After 8 weeks
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)
Time Frame: Pre-Treatment
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)
Time Frame: After 8 weeks
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
Time Frame: Pre-Treatment
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
Time Frame: After 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziauddin University

Investigators

  • Principal Investigator: Fouzia Hussain, MPhil, Ziauddin University Karachi, Sindh, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

July 20, 2022

Study Completion (Anticipated)

August 15, 2022

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4471121FHREH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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