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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568903
• Other study ID #: PD_Comprehensive_PT
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: December 1, 2017

Study information

• Verified date: June 2018
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 1, 2017
• Est. primary completion date: May 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	Tartu University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life: its change as a result of physiotherapy and change over time	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
Other	prevalence of pain: its change as a result of physiotherapy and change over time	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
Other	patient-specific complaints:its change as a result of physiotherapy and change over time	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
Other	difficulties in executing different activities of daily living: its change as a result of physiotherapy and change over time	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
Primary	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
Primary	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
Primary	"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	body composition (and changes in it in one year period)	it was assessed with DXA methodology	was assessed twice (during third and fourth assessment), with a timeperiod of one year in between
Secondary	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	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	Four square step test: its change as a result of physiotherapy and change over time	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
Secondary	Tinetti test: its change as a result of physiotherapy and change over time	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
Secondary	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	it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Secondary	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.	it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later