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

NCT ID: NCT03568903

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2017-12-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Comprehensive physical therapy

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tartu University Hospital

OTHER

Sponsor Role: collaborator

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Kadri Medijainen

Junior research fellow/Assistant of physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kadri Medijainen, MSc

Role: PRINCIPAL_INVESTIGATOR

Junior research fellow in physiotherapy

References

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.

Reference Type: DERIVED

PMID: 38588457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36602886 (View on PubMed)

Other Identifiers

PD_Comprehensive_PT

Identifier Type: -

Identifier Source: org_study_id