Clinical trial NCT01960985: Balance Training in Parkinson's Disease Using Cues
Official title: Efficiency of Motor Training Program Associated With Extrenal Cues on the Balance of Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: UPDRS
timeFrame: up to 30 weeks
Secondary outcomes:
measure: Berg Balance Scale (BBS) Berg Balance Scale
timeFrame: up to 30 weeks
measure: Dynamic Gait Index
timeFrame: up to 30 weeks
measure: Retropulsion test
timeFrame: up to 30 weeks
measure: Timed Up and Go test (TUG)
timeFrame: up to 30 weeks
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: up to 30 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Clinical Hospital
Study officials:
affiliation: University of Sao Paulo HCFMUSP
name: Tamine Capato, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Maria Elisa Piemonte, PhG
role: STUDY_DIRECTOR
References: