Protocol: Balance Training in Parkinson's Disease

NCT02488265 | Completed DMC

• 1 other identifier: Tamine Capato 02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Postural instability is a particularly incapacitating disorder, where loss of motor independence by Parkinson´s Disease (PD) patients marks a significant stage of disease onset. Evidence suggests that deficits in automatic motor control, sensory integration and attention are associated with lack of balance in PD. Physiotherapy, together with medication, plays an important role in the treatment of this state, although no consensus has been reached on the best treatment modality. The aim of this randomized controlled trial protocol is to evaluate the effects of balance training with rhythmical (BRT), which is a motor program to improve balance associated with rhythmical auditory cues (RACs)

Conditions

Parkinson Disease

Keywords

Parkinson´s disease; Physicaltherapy; Postural Balance; Gait; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Mini BESTest (MBESTest)

  Clinical balance assessment tool that aims to target different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.

  30 weeks

Secondary Outcomes (6)

• Berg Balance Scale (BBS)

  30 weeks

• UPDRS

  30 weeks

• Timed Up and Go test (TUG)

  30 weeks

• Push and Release Test

  30 weeks

• New Freezing of gait questonary (NFoG)

  30 weeks

Study Arms (2)

Motor training

EXPERIMENTAL

Balance training, Screening to prevent falls

Other: Balance Training; Other: Screening to prevent falls

Balance RhytmicalTraining

EXPERIMENTAL

Balance training, Screening to prevent falls

Other: Balance Training; Other: Screening to prevent falls

Interventions

Balance Training OTHER

Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).

Balance RhytmicalTraining; Motor training

Screening to prevent falls OTHER

Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.

Balance RhytmicalTraining; Motor training

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the subjects will be diagnosed by neurologists from the Movement Disorders Ambulatory Clinic of the University of São Paulo Faculty of Medicine Clinics Hospital, according to the UK Brain Bank criteria \[36\] and should be at H\&Y classification stage II or III, with a Mini Mental Status Examination (MMSE) \[37\] score of above 24.
• All patients should also present fall history.
• They should have the capacity to ambulate independently indoors without aid.

You may not qualify if:

• These are the presence of neurological, orthopedic or cardiopulmonary problems, an unstable medication regime, and an inability to understand or adhere to the protocol because of, for example, cognitive, auditory or visual problems.
• Patients receiving physical therapy training will also be excluded from the training.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo Clinical Hospital

São Paulo, Brazil

Location

Related Publications (4)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Capato TTC, de Vries NM, IntHout J, Ramjith J, Barbosa ER, Nonnekes J, Bloem BR. Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers. Phys Ther. 2020 Oct 30;100(11):2023-2034. doi: 10.1093/ptj/pzaa146.

  PMID: 32737973 DERIVED

• Capato TT, Tornai J, Avila P, Barbosa ER, Piemonte ME. Randomized controlled trial protocol: balance training with rhythmical cues to improve and maintain balance control in Parkinson's disease. BMC Neurol. 2015 Sep 7;15:162. doi: 10.1186/s12883-015-0418-x.

  PMID: 26347052 DERIVED

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

• Maria Elisa P Piemonte, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Tamine TC Capato, Master

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: May 30, 2017
• Study Completion: December 20, 2017
• Last Updated: November 2, 2018

Record last verified: 2018-11

Locations

BR (1)