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临床试验/NCT06215898
NCT06215898已完成不适用

Master's Thesis on the Investigation of the Effects of LSVT-BlG Protocol on Balance, Gait, Fatigue and Quality of Life in Parkinson's Patients

Izmir Bakircay University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Four Step Square Test

研究概览

简要总结

Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Treatment for Parkinson's disease is symptom-oriented. Treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions. The LSVT-BIG protocol, a physiotherapy and rehabilitation intervention, aims to overcome the insufficient speed-amplitude regulation that leads to low scaling of motion amplitude at any speed in Parkinson's disease. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and grand walking. Telerehabilitation is a system established for the online delivery of different rehabilitation services via telecommunication, and it has been reported that the LSVT-BIG protocol is a viable method with image-based video conferencing systems.

This study is a randomized controlled trial designed to examine the effect of the LSVT-BIG protocol on balance, gait, fatigue and quality of life. In this direction, thirty-four Parkinson's patients will be divided into two groups by randomization method after a preliminary evaluation including balance, gait, fatigue and quality of life variables. While the telerehabilitation-based LSVT-BIG protocol was applied to the experimental group for four weeks, no physiotherapy and rehabilitation interventions would be applied to the control group in addition to the medical treatment for the same period. At the end of four weeks, both groups will be evaluated again, including balance, gait, fatigue and quality of life variables. Evaluation data will be collected from patients through face-to-face evaluation methods and prepared questionnaires and scales. The obtained data will be evaluated using appropriate statistical methods using the SPSS statistical program.

详细描述

Parkinson's disease is a progressive, degenerative neurological disease manifested by motor and non-motor symptoms. Motor symptoms include resting tremor, bradykinesia, postural instability, rigidity, postural deformities, and gait disturbances. Non-motor symptoms include cognition and behavioral disorders, autonomic dysfunctions, sleep and sensory disturbances. These symptoms reduce the quality of life of patients and prevent participation in activities of daily living. Treatment for Parkinson's disease is symptom-oriented. These treatment options include medical treatment and surgical treatment, as well as physiotherapy and rehabilitation interventions.

Physiotherapy and rehabilitation interventions aim to maximize functional ability, minimize secondary complications, control unwanted side effects of medical treatment and possible motor fluctuations. For this purpose, intervention methods such as aerobic and strengthening exercises, balance and gait training, motor learning and movement strategies and the LSVT-BIG protocol are used in physiotherapy and rehabilitation programs.

LSVT-BIG protocol; derived from the Lee Silverman Voice Treatment protocol developed to improve hypophonia in Parkinson's patients, it is a treatment protocol that includes large amplitude body movements to increase both the speed and amplitude of functional movements. The goal of this protocol is to overcome the insufficient speed-amplitude regulation that leads to low scaling of the amplitude of motion at any given speed. Continuous feedback on motor performance and motion perception training in the protocol is used to offset the reduced gain in motor activities as a result of impaired sensorimotor processing. The protocol is applied for four weeks, four days a week, and each session is one hour. Each treatment session consists of four parts: maximal daily exercises, functional component tasks, hierarchy tasks, and big walking. In the study of Fishel et al., the LSVT-BIG protocol was applied to patients with intermediate Parkinson's disease. According to the results of this study, the LSVT-BIG protocol has a positive effect on balance, fall and walking variables. The study by Farley et al. showed that the LSVT-BIG protocol improved gait. It has been reported that improvement is higher especially in Hoehn Yahr stage 1 Parkinson's patients. The study by Sundaran et al suggests that balance ability in patients with Parkinson's is improved by the LSVT-BIG protocol, as assessed using the Berg Balance Scale.

Telerehabilitation is a system established for the remote delivery of different rehabilitation services via telecommunication. Online access provides advantages in terms of distance, time and cost. By taking the rehabilitation service beyond the hospital process, it allows patients to be treated in a comfortable and familiar environment. Intensive exercise programs such as the LSVT-BIG protocol impose a significant time and economic burden on patients, and there are limitations on access to the clinical setting and the practical applicability of the treatment. It is thought that these limitations can be eliminated by using the telerehabilitation method in practice. It has been reported that the LSVT-BIG protocol with telerehabilitation is a viable method with image-based video conferencing systems. The study by Fırat et al. showed that the LSVT-BIG protocol applied on the basis of telerehabilitation in Parkinson's patients gave positive results on quality of life, motor and non-motor symptoms. However, this study has some limitations such as the absence of a control group, not questioning patient satisfaction, and a small number of participants.

It is important to examine the effects of the LSVT-BIG protocol, which has been encountered in rare studies in the literature, on the motor symptoms of Parkinson's disease, since it is a current treatment approach. Few of these rare studies have used the telerehabilitation method despite the advantages it provides. In this direction, this study was planned to examine the effect of LSVT-BIG protocol applied on the basis of telerehabilitation on balance, gait, fatigue and quality of life in Parkinson's patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have had Parkinson's Disease
  • Grade 1-3 on the Hoehn-Yahr Scale
  • Stability of drug therapy taken in the last month
  • Being in the "ten" period of the patients
  • Volunteer to participate in the study

排除标准

  • Having other neurological, cardiovascular, or orthopedic disorder that may impair mobility have serious hearing and vision problems
  • Having an additional neurological or psychiatric illness
  • Not having the appropriate equipment for telerehabilitation sessions

结局指标

主要结局

Four Step Square Test

时间窗: 4 weeks

Four Step Square Test was used to assess patients' balance.

Berg Balance Assessment

时间窗: 4 weeks

Patients' balance was assessed with Berg Balance Scale

次要结局

  • Fatigue assessment(4 weeks)
  • Demographic data form(4 weeks)
  • Assesment of quality of life(4 weeks)
  • Assessment of the severity of Parkinson's disease(4 weeks)
  • Dynamic gait index evaluation(4 weeks)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Ulkü Pekmezci

Physiotherapist

Izmir Bakircay University

研究点 (2)

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