Effects of Visual Biofeedback Therapy in Parkinson's Patients

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325541
• Other study ID #: 4471121FHREH
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: April 2022
• Source: Ziauddin University
• Contact: Fouzia Hussain, MPhil
• Phone: 021-36629251
• Email: fouziaphysio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 15, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

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.

Locations

Country	Name	City	State
Pakistan	Ziauddin University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

References & Publications (11)

Aguilar-Navarro SG, Mimenza-Alvarado AJ, Palacios-García AA, Samudio-Cruz A, Gutiérrez-Gutiérrez LA, Ávila-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. — View Citation

Cabrera-Martos I, Jiménez-Martín AT, López-López L, Rodríguez-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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Negrini S, Bissolotti L, Ferraris A, Noro F, Bishop MD, Villafañe 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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