Balance Training in Parkinson's Disease Using Cues

NCT ID: NCT01960985

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-08-31

Brief Summary

Verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Detailed Description

The objective of this work is verifying the efficiency of motor training associated with visual and auditory cues on the balance, and postural anticipatory and compensatory adjustments of patients with Parkinson's Disease (PD), for prevent fall rate in people with PD. It is a double blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.

Forty two patients with idiopathic PD will take part in this study, at stages 2 to 3 of the Hoehn and Yahr Classification (HY). They are randomly assigned into one of 3 groups: one group receiving motor training associated to external cues (ET), the other one group performing motor training only (MT) and a third group receiving no treatment just generalize orientations. Performance in gait and balance are assessement before and after 10 training sessions (two 45-minute sessions per week) for the ET and MT groups, and before and after 5 weeks for the CG, using the BERG test (BT), Postural Stress Test (PST), Time Up and Go (TUG). Patients are also assessment for independence in daily life activities and motor performance using section II and III of the Unified Parkinson's Disease Rating Scale (UPDRS); for Quality of Life using the Parkinson's Disease Quality of Life (PDQL), and for emotional state by Beck's Depression Inventory (BDI). The training consist on: the experimental group receiving the motor program to balance associated to rhythmical auditory cues. The directions of the training were I. self-perception (strategies - Verbal and visual guidance); II. motor performance (Speed variation, Range of motion, Trunk mobility, Turning, balance exercices); III. Attention Strategies (Division of attention between guidance, environment and yourself movement, Maintenance of attention during all sets); IV. Cues.

The training program consisted on 5 weeks with 45 minutes duration, divided in 05 minutes warm-up, 30 minutes main part, 10 minutes cool down. The control group (CG) wasn't training just received orientations. Each session will consist on 05 minutes Warm-Up including: Muscle stretching, joint movements, upper and lower global, movement slowly and using wide joint movement range, and turning. The Main Part including: Head movement (bending, rotation, and leaning sideways), Axial and proximal movements, coordinated movements with Upper and Lower range and speed, Functional reach, weight shifts, stationary and walking gait with rhythmic and speed variation, postural reactions, trunk rotation, Balance exercises. And the last part is the Cool Down, including: Slow walk, breathing exercises associated to Upper limb movements and global muscular relaxation and stretching.

During the study there aren't changes on patient's usual medicine. The subjects will be reassessment after 4 and 30 weeks without the program training.

Conditions

Disturbance; Balance, Labyrinth; Parkinson´s Disease

Keywords

Balance, Postural; Parkinson´s Disease; H&Y 1-3; Exrecice; Postural adjustments; antecipatory postural; compensatory postural adjustments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physicaltherapy

Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.

Group Type: EXPERIMENTAL

Physicaltherapy

Intervention Type: OTHER

physiotherapy

Exprerimental group I - motor training balance training Exprerimental group II - motor training associated with visual and auditory cues on the balance training Control group - recived general orientations.

Group Type: EXPERIMENTAL

Physicaltherapy

Intervention Type: OTHER

Interventions

Physicaltherapy

Intervention Type: OTHER

Other Intervention Names

balance training

Eligibility Criteria

Inclusion Criteria

1. Elderly

2. The patient is able to provide informed consent.

3. Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist

4. Hoehn and Yahr Stage 1-3

5. Able to ambulate without an assistive device

6. On stable doses of Parkinson's medications prior to study onset

Exclusion Criteria

1. Mini Mental Status Exam (MMSE) < 24

2. Change in Parkinson's medications in the duration of study

3. Uncontrolled orthostasis

4. Symptomatic coronary artery disease

5. Fracture of lower limb prior to study onset

6. Other neurologic diagnosis

7. Physical therapy before and during to study duration

8. Significant camptocormia

9. Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamine Capato, Master

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo HCFMUSP

Maria Elisa Piemonte, PhG

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

University of Sao Paulo Clinical Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Other Identifiers

Tamine Capato 01

Identifier Type: -

Identifier Source: org_study_id