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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Comprehensive physical therapy
Sponsored by
University of Tartu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson Disease focused on measuring Parkinson Disease, Gait, Physical therapy, functional performance, group therapy

Eligibility Criteria

60 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time
    Gait speed was calculated based an the performance of Timed up and Go test
    Gait speed during transitioning from standing to walking and its change as a result of physiotherapy and change over time
    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
    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

    Secondary Outcome Measures

    body composition (and changes in it in one year period)
    it was assessed with DXA methodology
    Timed-up-and-go test: its change as a result of physiotherapy and change over time
    The duration of Timed up and go test, executed with a turn over both shoulders was used
    Four square step test: its change as a result of physiotherapy and change over time
    The duration of Four square step test,was used
    Tinetti test: its change as a result of physiotherapy and change over time
    The Tinetti test was executed and the score was used
    Range of motion: its change as a result of physiotherapy and change over time
    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
    Assessment of handwriting:its change as a result of physiotherapy and change over time
    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.

    Full Information

    First Posted
    May 15, 2018
    Last Updated
    June 13, 2018
    Sponsor
    University of Tartu
    Collaborators
    Tartu University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03568903
    Brief Title
    Changes in Functional Performance in Individuals With Parkinson's Disease Following 2-month Physiotherapy Intervention
    Official Title
    Functional Performance in Individuals With Parkinson's Disease: Changes Following 2-month Physiotherapy Intervention in Small Groups and Impact of Disease Progression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2013 (Actual)
    Primary Completion Date
    May 15, 2015 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Tartu
    Collaborators
    Tartu University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson Disease, Gait, Physical therapy, functional performance, group therapy

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Comprehensive physical therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time
    Description
    Gait speed was calculated based an the performance of Timed up and Go test
    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
    Title
    Gait speed during transitioning from standing to walking and its change as a result of physiotherapy and change over time
    Description
    Gait speed was calculated based an the performance of Short Physical Performance Battery gait test
    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
    Title
    "Pure" gait speed and its change as a result of physiotherapy and change over time
    Description
    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
    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
    Secondary Outcome Measure Information:
    Title
    body composition (and changes in it in one year period)
    Description
    it was assessed with DXA methodology
    Time Frame
    was assessed twice (during third and fourth assessment), with a timeperiod of one year in between
    Title
    Timed-up-and-go test: its change as a result of physiotherapy and change over time
    Description
    The duration of Timed up and go test, executed with a turn over both shoulders was used
    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
    Title
    Four square step test: its change as a result of physiotherapy and change over time
    Description
    The duration of Four square step test,was used
    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
    Title
    Tinetti test: its change as a result of physiotherapy and change over time
    Description
    The Tinetti test was executed and the score was used
    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
    Title
    Range of motion: its change as a result of physiotherapy and change over time
    Description
    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
    Time Frame
    it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
    Title
    Assessment of handwriting:its change as a result of physiotherapy and change over time
    Description
    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.
    Time Frame
    it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
    Other Pre-specified Outcome Measures:
    Title
    Quality of life: its change as a result of physiotherapy and change over time
    Description
    it was assessed with PDQ-39 questionaire
    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
    Title
    prevalence of pain: its change as a result of physiotherapy and change over time
    Description
    it was assessed with patient interview
    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
    Title
    patient-specific complaints:its change as a result of physiotherapy and change over time
    Description
    it was assessed with patient interview
    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
    Title
    difficulties in executing different activities of daily living: its change as a result of physiotherapy and change over time
    Description
    it was assessed with patient interview
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    81 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Not meeting the inclusion criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kadri Medijainen, MSc
    Organizational Affiliation
    Junior research fellow in physiotherapy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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