Balance Training in Parkinson's Disease Using Cues

Parkinson´s Disease Clinical Trial

Official title:

Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960985
• Other study ID #: Tamine Capato 01
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2013
• Last updated: June 29, 2015
• Start date: August 2006
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disturbance; Balance, Labyrinth
• Parkinson Disease
• Parkinson´s Disease

Intervention

Other:
• Physicaltherapy

Locations

Country	Name	City	State
Brazil	University of Sao Paulo Clinical Hospital	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPDRS	The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease	up to 30 weeks	No
Secondary	Berg Balance Scale (BBS) Berg Balance Scale	Berg Balance Scale assesses the functional balance of patients with Parkinson´s disease. It is a clinic assessment of patient that evaluate the antecipatory postural adjustments and the performance of patient to stand up and sit down, turn on and step, among others situations.	up to 30 weeks	No
Secondary	Dynamic Gait Index	The scale assesses the ability to adapt the gait during motor tasks with different demands	up to 30 weeks	No
Secondary	Retropulsion test	The Retropulsion test, by which an unexpected, quick and firm jerk on the shoulder is given in a backward direction.It is a clinic assessment of patient that evaluate the compensatory postural adjustments	up to 30 weeks	No
Secondary	Timed Up and Go test (TUG)	The Timed Up and Go test is a short, practical test by which gait and balance are tested	up to 30 weeks	No
Secondary	Balance Evaluation Systems Test (BESTest)	Clinical balance assessment tool that aims to target 6 different balance control systems so that specific rehabilitation approaches can be designed for different balance deficits.	up to 30 weeks	No