Changes in Functional Performance in Individuals With Parkinson's Disease Following 2-month Physiotherapy Intervention

June 13, 2018 updated by: Kadri Medijainen, University of Tartu

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Other: Comprehensive physical therapy
Each session included exercises for posture, strength, range of motion, balance. In addition, different transfers and gait training was performed. Each session began with exercises in laying position (15 minutes), thereafter exercises in sitting were performed for 10 minutes. Then different exercises in standing position were performed for 15 minutes, followed by 10 minutes of gait training. 10 minutes of exercises for manual dexterity and upper limb function ended the session.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time
Time Frame: 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
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 during transitioning from standing to walking and its change as a result of physiotherapy and change over time
Time Frame: 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
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
"Pure" gait speed and its change as a result of physiotherapy and change over time
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition (and changes in it in one year period)
Time Frame: was assessed twice (during third and fourth assessment), with a timeperiod of one year in between
it was assessed with DXA methodology
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
Time Frame: 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
The duration of Timed up and go test, executed with a turn over both shoulders was used
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
Time Frame: 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
The duration of Four square step test,was used
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
Tinetti test: its change as a result of physiotherapy and change over time
Time Frame: 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
The Tinetti test was executed and the score was used
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
Time Frame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Range of motion of major joints (shoulder, hip, knee, ankle) were measured goniometrically. Spinal ROM (including neck) was measured with tapemeasure, aswell as the excursion of the ribcage during maximal inspiration and expiration
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
Time Frame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
To assess the impact of visual cues on handwriting, patients were instructed to write one simple and one complex sentence on white, striped and squared paper. During assessment, the speed of writing was registered.
it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life: its change as a result of physiotherapy and change over time
Time Frame: 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
it was assessed with PDQ-39 questionaire
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
prevalence of pain: its change as a result of physiotherapy and change over time
Time Frame: 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
it was assessed with patient interview
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
patient-specific complaints:its change as a result of physiotherapy and change over time
Time Frame: 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
it was assessed with patient interview
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
difficulties in executing different activities of daily living: its change as a result of physiotherapy and change over time
Time Frame: 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
it was assessed with patient interview
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Collaborators

Tartu University Hospital

Investigators

  • Principal Investigator: Kadri Medijainen, MSc, Junior research fellow in physiotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

May 15, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD_Comprehensive_PT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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