Effects of Home Rehabilitation of Balance Based on Functional Exercises in People With Parkinson's Disease

NCT04963894 | Unknown

• 1 other identifier: 1686831
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

Balance rehabilitation programs in people with Parkinson's disease (PD) that include functional exercises, i.e. using tasks of daily living in training, show improvements in variables related to balance and gait. In previous studies, the advantage of taking into account the specificity of the task and the inclusion of specific objectives for the motor rehabilitation of people with PD has been observed. The interventions with the best results are usually carried out in hospital centers or rehabilitation gyms and, in groups of people. Due to the situation experienced since last March 2020, due to the Covid-19 pandemic, group rehabilitation programs have been affected, especially in those pathologies that involve older age groups such as PD. For this reason, the need to transfer therapies to the home is considered, as well as to make people aware of the importance of continued rehabilitation, even from other settings. In the present study, we propose a rehabilitation program at home for people with Parkinson's disease based on balance with functional exercises, which will be compared with a home control group of people with PD that stay at home without any physical rehabilitation, and a conventional group physiotherapy program carried out in a rehabilitation gym in groups of 6 people. The effects of the experimental intervention and the control groups will be evaluated on outcomes related to balance using a dynamometric platform and outcomes related to gait through 3D photogrammetry.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Biomechanics of Balance; Biomechanics of gait; Functional rehabilitation; Functional assessment

Outcome Measures

Primary Outcomes (1)

• Mean swept area of the Centre of Pressure (COP) during the functional motor balance test (Romberg test with an arms task)

  Area in which the participant sway occurs on the dynamometric platform, calculated by the movement of the COP from the start of the test to the end of it (mm2). During the motor functional test, the patient maintains balance while performing a task with the upper limbs below 90º of shoulder flexion.

  4 months

Study Arms (3)

Home functional balance physiotherapy

EXPERIMENTAL

Participants perform physical therapy at home individually with a physical therapist. The experimental program of the study of balance exercise in functional context is implemented.

Other: Home functional balance physiotherapy

Home functional daily activity

NO INTERVENTION

Participants stay in home without physiotherapy. Participants maintained their normal daily activities, which included housework, shopping, or daily walks.

Conventional physiotherapy

ACTIVE COMPARATOR

Participants perform physical therapy in a rehabilitation gym and in groups of 10 people. The conventional program of physiotherapy is implemented.

Other: Conventional physiotherapy

Interventions

Home functional balance physiotherapy OTHER

Experimental physiotherapy program is carried out at home to improve the balance of people with Parkinson's disease through exercises that simulate everyday functional contexts.

Home functional balance physiotherapy

Conventional physiotherapy OTHER

Conventional control physiotherapy program is carried out face-to-face in a rehabilitation gym and in groups of 6 people. The conventional program of physiotherapy includes conventional therapeutic goals of rehabilitation in people with Parkinson's disease.

Conventional physiotherapy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To present diagnosis of idiopathic Parkinson's disease
• To have H\&Y stage between I and IV
• To perform independent gait with or without technical assistance
• To have stable parkinsonian medication for at least 1 month prior to the start of the intervention.

You may not qualify if:

• To have other diseases that affect balance or walking
• To present other diagnosed neurological pathologies
• To present chronic uncontrolled diseases
• To participate in another physical rehabilitation program during the intervention period or 1 month before starting it
• To unknow one of the two official languages of the Valencian Community (Spain).

Sponsors & Collaborators

• University of Valencia: lead
• Asociación Parkinson Valencia: collaborator

Study Sites (2)

University of Valencia

Valencia, 46010, Spain

Location

Asociación Parkinson Valencia

Valencia, 46014, Spain

Location

Related Publications (9)

• Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. Epub 2015 Dec 10.

  PMID: 26661467 BACKGROUND

• Santos SM, da Silva RA, Terra MB, Almeida IA, de Melo LB, Ferraz HB. Balance versus resistance training on postural control in patients with Parkinson's disease: a randomized controlled trial. Eur J Phys Rehabil Med. 2017 Apr;53(2):173-183. doi: 10.23736/S1973-9087.16.04313-6. Epub 2016 Nov 23.

  PMID: 27879959 BACKGROUND

• Atterbury EM, Welman KE. Balance training in individuals with Parkinson's disease: Therapist-supervised vs. home-based exercise programme. Gait Posture. 2017 Jun;55:138-144. doi: 10.1016/j.gaitpost.2017.04.006. Epub 2017 Apr 4.

  PMID: 28445854 BACKGROUND

• Klamroth S, Steib S, Devan S, Pfeifer K. Effects of Exercise Therapy on Postural Instability in Parkinson Disease: A Meta-analysis. J Neurol Phys Ther. 2016 Jan;40(1):3-14. doi: 10.1097/NPT.0000000000000117.

  PMID: 26655098 BACKGROUND

• Leavy B, Joseph C, Lofgren N, Johansson H, Hagstromer M, Franzen E. Outcome Evaluation of Highly Challenging Balance Training for People With Parkinson Disease: A Multicenter Effectiveness-Implementation Study. J Neurol Phys Ther. 2020 Jan;44(1):15-22. doi: 10.1097/NPT.0000000000000298.

  PMID: 31834166 BACKGROUND

• Wallen MB, Hagstromer M, Conradsson D, Sorjonen K, Franzen E. Long-term effects of highly challenging balance training in Parkinson's disease-a randomized controlled trial. Clin Rehabil. 2018 Nov;32(11):1520-1529. doi: 10.1177/0269215518784338. Epub 2018 Jul 2.

  PMID: 29962227 BACKGROUND

• Rennie L, Opheim A, Dietrichs E, Lofgren N, Franzen E. Highly challenging balance and gait training for individuals with Parkinson's disease improves pace, rhythm and variability domains of gait - A secondary analysis from a randomized controlled trial. Clin Rehabil. 2021 Feb;35(2):200-212. doi: 10.1177/0269215520956503. Epub 2020 Sep 28.

  PMID: 32985265 BACKGROUND

• Liu C, Shiroy DM, Jones LY, Clark DO. Systematic review of functional training on muscle strength, physical functioning, and activities of daily living in older adults. Eur Rev Aging Phys Act. 1 de octubre de 2014;11(2):95-106.

  BACKGROUND

• Serrao M, Pierelli F, Sinibaldi E, Chini G, Castiglia SF, Priori M, Gimma D, Sellitto G, Ranavolo A, Conte C, Bartolo M, Monari G. Progressive Modular Rebalancing System and Visual Cueing for Gait Rehabilitation in Parkinson's Disease: A Pilot, Randomized, Controlled Trial With Crossover. Front Neurol. 2019 Aug 29;10:902. doi: 10.3389/fneur.2019.00902. eCollection 2019.

  PMID: 31543859 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

• Constanza San Martín Valenzuela, PhD.

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Subjects will participate in a baseline assessment session (T0) before rehabilitative treatment, followed by random allocation to the Experimental group (8 weeks of functional balance physiotherapy) or the Home control group (daily functional activity). After these 8 weeks, all the participants will develop a second assessment session (T1) and rested for the next 8 weeks to develop after that the follow-up assessment session (T2). At this time, patients from the Home control group will be switch to the Experimental group, and participants from the Experimental group will follow a 4-month of inactivity wash-out period. After this, they will carry out the T0, T1, and T2 evaluations following the Home control group protocol. Additionally, a third group of participants with Parkinson's disease who habitually developed conventional physiotherapy in a rehabilitation gym and in groups of 6 people, were evaluated (Conventional control group) at T0, T1 and T2.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: September 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)