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临床试验/NCT04187963
NCT04187963已完成不适用

Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease

Universitatea de Medicina si Farmacie Iuliu Hatieganu0 个研究点目标入组 60 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Change in Walking speed

研究概览

简要总结

Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Physical therapy interventions are an important part of the non-pharmacological treatment for Parkinson disease. The purpose of this study was to assess whether there is a different outcome regarding improvement of walking speed, when applying a physical therapy program in an individual or in a group manner.

A prospective, observational, cohort type study on 60 patients with Parkinson disease was carried out between November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients were randomly divided into 2 groups, and were prescribed either individual (1 patient and 1 physical therapist) or group physical therapy (6 patients and 1 physical therapist). Treatment protocol included 10 sessions of physical therapy, in the same room setting and performed the same routine of exercises, except for the 3 breaks during the sessions in the group therapy for informal socialization. Walking speed was measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment.

Patients with PD could benefit more from a group physical therapy program, as gait speed increased significantly. The group approach facilitates interactions and is cost-effective, as it requires only one therapist and more patients.

详细描述

The current study was carried out during November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. A total of 60 subjects diagnosed with typical, idiopathic PD participated in this study.

All patients met the following inclusion criteria: (1) stable medication usage; (2) Hoehn and Yahr stage 2, 3 or 4; (3) ability to walk independently or by using an assistive walking device; (4) age 50 to 70 years; (5) no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24); (6) no other severe neurologic, cardiopulmonary or orthopedic disorders; and (7) not having participated in a PT or rehabilitation program in the previous 2 months.

The patients were randomly divided into 2 treatment groups: group physical therapy -GPT (n=30) and individual physical therapy - IPT (n=30).

Treatment protocol for each group included 10 sessions of physical therapy, each 1.5 hour long, on a daily basis for 2 weeks. All treatment sessions occurred at the same time of day throughout the study, in the morning, 60-90 minutes after intake of pharmaceutical treatment for PD. For the GPT, there were groups of 6 patients, supervised by 1 physical therapist. The group sizes were kept small to promote efficiency and motivation. The patients undertaking IPT were alone with the physical therapist during the sessions. Both groups had their encounters in the same physical therapy room setting.

The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.

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
Single (Investigator)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stable medication usage;
  • Hoehn and Yahr stage 2, 3 or 4;
  • ability to walk independently or by using an assistive walking device;
  • age 50 to 70 years;
  • no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24);
  • no other severe neurologic, cardiopulmonary or orthopedic disorders;
  • not having participated in a PT or rehabilitation program in the previous 2 months.

排除标准

  • not stable medication usage;
  • Hoehn and Yahr stage 1;
  • inability to walk independently or by using an assistive walking device;
  • age less than 50 and more than 70 years;
  • severe cognitive impairments (Mini-Mental State Examination - MMSE score, below 24);
  • other severe neurologic, cardiopulmonary or orthopedic disorders;
  • having participated in a PT or rehabilitation program in the previous 2 months.

结局指标

主要结局

Change in Walking speed

时间窗: at baseline and after 10 days

the 10-meter walking test.

Change in Walking speed (meters/seconds)

时间窗: at baseline and after 10 days

the 6-minute walking test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciubean Alina Deniza

Principal investigator

Universitatea de Medicina si Farmacie Iuliu Hatieganu

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