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Effects of Visual Biofeedback Therapy in Parkinson's Patients

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Visual Biofeedback Therapy
Conventional Balance exercise
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

60 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ziauddin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arms 1

Arms 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Balance
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Balance
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
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
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
Cognitive Function
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Cognitive Function
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
April 12, 2022
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05325541
Brief Title
Effects of Visual Biofeedback Therapy in Parkinson's Patients
Official Title
Effects of Visual Biofeedback Therapy on Balance, Freezing of Gait and Cognition Among Stage III Parkinson's Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
All participants will be blinded regarding treatment. 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.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arms 1
Arm Type
Experimental
Arm Description
Game-Based Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.
Arm Title
Arms 2
Arm Type
Placebo Comparator
Arm Description
Conventional Rehabilitation received total 24 sessions, 45-50 minutes/session, 3 times/week for total 8 weeks.
Intervention Type
Device
Intervention Name(s)
Visual Biofeedback Therapy
Intervention Description
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
Behavioral
Intervention Name(s)
Conventional Balance exercise
Intervention Description
Conventional Balance exercises will be given for 24 sessions, comprising of 45-50 minutes, 3 times/week for the duration of 8 weeks.
Primary Outcome Measure Information:
Title
Balance
Description
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Time Frame
Baseline
Title
Balance
Description
Balance function will be assessed through Functional Reach Test FRT among stage III PD patients where high values indicates increase in balance function
Time Frame
After 8 weeks
Title
Freezing of Gait (FOG)
Description
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Time Frame
Pre-Treatment
Title
Freezing of Gait (FOG)
Description
Freezing of Gait will be assessed through FOG Questionnaire among stage III PD patients where low values indicates decrease in freezing of gait
Time Frame
After 8 weeks
Title
Cognitive Function
Description
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Time Frame
Pre-Treatment
Title
Cognitive Function
Description
Cognitive Function will be assessed using Montreal Cognitive Assessment among stage III PD patients where high values indicates increase in Cognitive Function
Time Frame
After 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fouzia Hussain, MPhil
Phone
021-36629251
Ext
5
Email
fouziaphysio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fouzia Hussain, MPhil
Organizational Affiliation
Ziauddin University Karachi, Sindh, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fouzia Hussain, MPhil
Phone
021-36629251
Ext
5
Email
fouziaphysio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30286846
Citation
Aguilar-Navarro SG, Mimenza-Alvarado AJ, Palacios-Garcia AA, Samudio-Cruz A, Gutierrez-Gutierrez LA, Avila-Funes JA. Validity and Reliability of the Spanish Version of the Montreal Cognitive Assessment (MoCA) for the Detection of Cognitive Impairment in Mexico. Rev Colomb Psiquiatr (Engl Ed). 2018 Oct-Dec;47(4):237-243. doi: 10.1016/j.rcp.2017.05.003. Epub 2017 Jul 29. English, Spanish.
Results Reference
background
PubMed Identifier
31981631
Citation
Feng YS, Yang SD, Tan ZX, Wang MM, Xing Y, Dong F, Zhang F. The benefits and mechanisms of exercise training for Parkinson's disease. Life Sci. 2020 Mar 15;245:117345. doi: 10.1016/j.lfs.2020.117345. Epub 2020 Jan 22.
Results Reference
background
PubMed Identifier
29337023
Citation
Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
Results Reference
background
PubMed Identifier
30153396
Citation
Gupta DK, Fahn S, Tatsuoka C, Kang UJ. Hoehn and Yahr stage 3 and postural stability item in the movement disorder society-unified Parkinson's disease rating scale. Mov Disord. 2018 Jul;33(7):1188-1189. doi: 10.1002/mds.27453. No abstract available.
Results Reference
background
PubMed Identifier
32071940
Citation
Hulzinga F, Nieuwboer A, Dijkstra BW, Mancini M, Strouwen C, Bloem BR, Ginis P. The New Freezing of Gait Questionnaire: Unsuitable as an Outcome in Clinical Trials? Mov Disord Clin Pract. 2020 Jan 14;7(2):199-205. doi: 10.1002/mdc3.12893. eCollection 2020 Feb.
Results Reference
background
PubMed Identifier
27382292
Citation
Khan S, Nabi G, Naeem M, Ali L, Silburn PA, Mellick GD. A door-to-door survey to estimate the prevalence of Parkinsonism in Pakistan. Neuropsychiatr Dis Treat. 2016 Jun 21;12:1499-506. doi: 10.2147/NDT.S86329. eCollection 2016.
Results Reference
background
PubMed Identifier
28167167
Citation
Negrini S, Bissolotti L, Ferraris A, Noro F, Bishop MD, Villafane JH. Nintendo Wii Fit for balance rehabilitation in patients with Parkinson's disease: A comparative study. J Bodyw Mov Ther. 2017 Jan;21(1):117-123. doi: 10.1016/j.jbmt.2016.06.001. Epub 2016 Jun 11.
Results Reference
background
PubMed Identifier
31355092
Citation
Taimur M, Shah MAA, Ali M, Barry HD, Hussain SZM, Shahzad H, Rizwan A. Frequency of Cognitive Impairment in Patients with Parkinson's Disease. Cureus. 2019 May 23;11(5):e4733. doi: 10.7759/cureus.4733.
Results Reference
background
PubMed Identifier
32660512
Citation
Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y.
Results Reference
background
PubMed Identifier
31498138
Citation
Santos P, Machado T, Santos L, Ribeiro N, Melo A. Efficacy of the Nintendo Wii combination with Conventional Exercises in the rehabilitation of individuals with Parkinson's disease: A randomized clinical trial. NeuroRehabilitation. 2019;45(2):255-263. doi: 10.3233/NRE-192771.
Results Reference
background
PubMed Identifier
32349543
Citation
Cabrera-Martos I, Jimenez-Martin AT, Lopez-Lopez L, Rodriguez-Torres J, Ortiz-Rubio A, Valenza MC. Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):764-772. doi: 10.1177/0269215520918631. Epub 2020 Apr 29.
Results Reference
background

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Effects of Visual Biofeedback Therapy in Parkinson's Patients

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