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临床试验/NCT01960985
NCT01960985已完成3 期

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2006年8月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
42
试验地点
1
主要终点
UPDRS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The patient is able to provide informed consent.
  • •Definitive Idiopathic Parkinson's Disease as diagnosed by a Neurologist
  • •Hoehn and Yahr Stage 1-3
  • •Able to ambulate without an assistive device
  • •On stable doses of Parkinson's medications prior to study onset

排除标准

  • •Mini Mental Status Exam (MMSE) < 24
  • •Change in Parkinson's medications in the duration of study
  • •Uncontrolled orthostasis
  • •Symptomatic coronary artery disease
  • •Fracture of lower limb prior to study onset
  • •Other neurologic diagnosis
  • •Physical therapy before and during to study duration
  • •Significant camptocormia
  • •Any medical condition which the physician investigator determines would compromise the safety of exercise program for the subject.

研究组 & 干预措施

physiotherapy

Experimental

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.

干预措施: Physicaltherapy (Other)

Physicaltherapy

Experimental

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.

干预措施: Physicaltherapy (Other)

结局指标

主要结局

UPDRS

时间窗: up to 30 weeks

The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease

次要结局

  • Retropulsion test(up to 30 weeks)
  • Balance Evaluation Systems Test (BESTest)(up to 30 weeks)
  • Berg Balance Scale (BBS) Berg Balance Scale(up to 30 weeks)
  • Dynamic Gait Index(up to 30 weeks)
  • Timed Up and Go test (TUG)(up to 30 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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