Clinical trial NCT03568903: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Gait
Physical therapy
functional performance
group therapy
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
First posted: 2018-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 60
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Exclusion Criteria:

Not meeting the inclusion criteria

Primary outcomes:
measure: Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time
timeFrame: 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
measure: Gait speed during transitioning from standing to walking and its change as a result of physiotherapy and change over time
timeFrame: 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
measure: "Pure" gait speed and its change as a result of physiotherapy and change over time
timeFrame: 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:
measure: body composition (and changes in it in one year period)
timeFrame: was assessed twice (during third and fourth assessment), with a timeperiod of one year in between
measure: Timed-up-and-go test: its change as a result of physiotherapy and change over time
timeFrame: 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
measure: Four square step test: its change as a result of physiotherapy and change over time
timeFrame: 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
measure: Tinetti test: its change as a result of physiotherapy and change over time
timeFrame: 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
measure: Range of motion: its change as a result of physiotherapy and change over time
timeFrame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
measure: Assessment of handwriting:its change as a result of physiotherapy and change over time
timeFrame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Other outcomes:
measure: Quality of life: its change as a result of physiotherapy and change over time
timeFrame: 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
measure: prevalence of pain: its change as a result of physiotherapy and change over time
timeFrame: 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
measure: patient-specific complaints:its change as a result of physiotherapy and change over time
timeFrame: 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
measure: difficulties in executing different activities of daily living: its change as a result of physiotherapy and change over time
timeFrame: 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
Locations:
Study officials:
affiliation: Junior research fellow in physiotherapy
name: Kadri Medijainen, MSc
role: PRINCIPAL_INVESTIGATOR
References: