Effects of Visual Biofeedback Therapy in Parkinson's Patients

NCT05325541 | Unknown

• 1 other identifier: 4471121FHREH
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Arms 1

EXPERIMENTAL

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

Device: Visual Biofeedback Therapy

Arms 2

PLACEBO COMPARATOR

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

Behavioral: Conventional Balance exercise

Interventions

Visual Biofeedback Therapy 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 1

Conventional Balance exercise BEHAVIORAL

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

Arms 2

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease of age between 60-79 years.
• Diagnosed PD stage III.

You may not qualify if:

• Other neurological problems (Multiple sclerosis, amyotrophic lateral sclerosis and myasthenia gravis).
• Migraine.
• Auditory or visual deficits.
• Orthostatic hypotension.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (11)

• 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.

  PMID: 30286846 BACKGROUND

• 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.

  PMID: 31981631 BACKGROUND

• 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.

  PMID: 29337023 BACKGROUND

• 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.

  PMID: 30153396 BACKGROUND

• 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.

  PMID: 32071940 BACKGROUND

• 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.

  PMID: 27382292 BACKGROUND

• 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.

  PMID: 28167167 BACKGROUND

• 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.

  PMID: 31355092 BACKGROUND

• 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.

  PMID: 32660512 BACKGROUND

• 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.

  PMID: 31498138 BACKGROUND

• 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.

  PMID: 32349543 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Fouzia Hussain, MPhil

  Ziauddin University Karachi, Sindh, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fouzia Hussain, MPhil

CONTACT

021-36629251; fouziaphysio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 13, 2022
• Study Start: March 1, 2022
• Primary Completion: July 20, 2022
• Study Completion: August 15, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)