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临床试验/NCT03568903
NCT03568903已完成不适用

Functional Performance in Individuals With Parkinson's Disease: Changes Following 2-month Physiotherapy Intervention in Small Groups and Impact of Disease Progression

University of Tartu0 个研究点目标入组 44 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
主要终点
Gait speed during transitioning from standing to walking and its change as a result of physiotherapy and change over time

研究概览

简要总结

Aim of current study was to evaluate the effect of a 2-month comprehensive physiotherapy intervention on different aspects of functional performance. In addition, progression of PD motor symptoms (using standardized clinical tests for the assesment) was of interest

详细描述

The aim of current study was to enroll 50 patients with Parkinson's disease (PD) and randomly assign them into intervention and control group. Patients were randomly contacted through the epidemiological database of patients with Parkinson' disease of South-Estonia. 44 participants agreed to come to the baseline assessment including:

  • Timed-Up-And-Go Test Battery
  • Four square step test
  • Physical performance test
  • Short Physical Performance
  • 10-m walk test
  • Grooved Purdue Pegboard test
  • Assessment of range of motion In addition, current disease status was assessed using Unified Parkinson Disease Rating Scale, Mini Mental Sate Examination. Further, quality of life was assessed using PDQ-39, hand-writing was recorded using white, squared and striped paper and freezing of gait questionaire (FOG-Q) was administered. Within a week from baseline assessment participants randomly assigned to intervention group, started physiotherapy intervention. The intervention was carried out in small groups (3 people in a group) and was carried out as out-patient physiotherapy during 8 week period. During each week 2 sessions with a length of an hour were scheduled. Within a week of the last therapy session, second assessment was conducted (for control group the second assessment was carried out ten weeks post-baseline assessment.

Third assessment was assigned one year after (then the same assessment was performed, in addition body composition was analysed using DXA), forth assessment an other year later.

During forth assessment 15 members starting in the intervention group and 10 starting in the control group participated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of idiopathic Parkinson Disease
  • age within the age limits
  • no other untreated medical conditions that might affect gait or postural stability
  • able to walk without assistive device
  • score of Mini Mental State Examination above 24
  • no other neurological conditions in medical anamnesis

排除标准

  • Not meeting the inclusion criteria

研究组 & 干预措施

Intervention group

Experimental

Comprehensive physical therapy intervention in small groups (3 members), altogether 16 sessions were performed during a period of 8 weeks (twice a week). Each session lasted 1 hour.

干预措施: Comprehensive physical therapy (Other)

Control group

No Intervention

Control group members did not receive any specific intervention during study period, but if needed, medical treatment (medication, it's dosage etc) of Parkinson Disease was changed during study period. They were assigned to individual therapy after the study period.

结局指标

主要结局

Gait speed during transitioning from standing to walking and its change as a result of physiotherapy and change over time

时间窗: it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later

Gait speed was calculated based an the performance of Short Physical Performance Battery gait test

"Pure" gait speed and its change as a result of physiotherapy and change over time

时间窗: it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later

Gait speed was calculated based an the performance of 10 m walk test, with excluding the acceleration and deceleration phase (duration of the intermediate 6-meters was measured and based on that gait speed was calculated

Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time

时间窗: it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later

Gait speed was calculated based an the performance of Timed up and Go test

次要结局

  • body composition (and changes in it in one year period)(was assessed twice (during third and fourth assessment), with a timeperiod of one year in between)
  • Timed-up-and-go test: its change as a result of physiotherapy and change over time(it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later)
  • Four square step test: its change as a result of physiotherapy and change over time(it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later)
  • Range of motion: its change as a result of physiotherapy and change over time(it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later)
  • Assessment of handwriting:its change as a result of physiotherapy and change over time(it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later)
  • Tinetti test: its change as a result of physiotherapy and change over time(it was assessed during all the assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later, forth assessment was conducted another year later)

研究者

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

Kadri Medijainen

Junior research fellow/Assistant of physiotherapy

University of Tartu

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