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

NCT03568903 | Completed

• 1 other identifier: PD_Comprehensive_PT
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Gait; Physical therapy; functional performance; group therapy

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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 Outcomes (6)

• 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

• 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

• 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

Other Outcomes (4)

• Quality of life: 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

• prevalence of pain: 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

• patient-specific complaints: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

Study Arms (2)

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.

Other: Comprehensive physical therapy

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.

Interventions

Comprehensive physical therapy OTHER

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.

Intervention group

Eligibility Criteria

• Age: 60 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Tartu: lead
• Tartu University Hospital: collaborator

Related Publications (2)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kadri Medijainen, MSc

  Junior research fellow in physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior research fellow/Assistant of physiotherapy

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 26, 2018
• Study Start: February 1, 2013
• Primary Completion: May 15, 2015
• Study Completion: December 1, 2017
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share