Parkinson DiseaseNCT03568903
Changes in Functional Performance in Individuals With Parkinson's Disease Following 2-month Physiotherapy Intervention
A study testing Comprehensive physical therapy in people with Parkinson Disease, run by University of Tartu.
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 Read more about this study
- Who is it for?
- Ages 60 to 81 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Comprehensive physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting the inclusion criteria
About this study
Official title: Functional Performance in Individuals With Parkinson's Disease: Changes Following 2-month Physiotherapy Intervention in Small Groups and Impact of Disease Progression
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
Read the 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
- Being tested
- Comprehensive physical therapy
- Keywords
- Parkinson Disease, Gait, Physical therapy, functional performance, group therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
it was assessed with DXA methodology
Measured: 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
The duration of Timed up and go test, executed with a turn over both shoulders was used
Measured: 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
The duration of Four square step test,was used
Measured: 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
The Tinetti test was executed and the score was used
Measured: 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
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
Measured: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
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.
Measured: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Feb 2013
- Primary completion15 May 2015
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital
- Responsible party
- Principal investigator, Kadri Medijainen, University of Tartu
- Investigators
- Kadri Medijainen, MSc, Principal investigator, Junior research fellow in physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568903
- Sponsor's protocol ID
- PD_Comprehensive_PT
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38588457Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Performance in Individuals With Parkinson's Disease: Changes Following 2-month Physiotherapy Intervention in Small Groups and Impact of Disease Progression
- ClinicalTrials.gov ID
- NCT03568903
- Acronym / sponsor ID
- PD_Comprehensive_PT
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Gait, Physical therapy, functional performance, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 15 May 2015 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Comprehensive physical therapyComprehensive 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 | 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. |
Who may qualify
- Ages
- 60 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive physical therapyEach 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. | Other | Intervention group |
Primary outcome
Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time
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
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
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
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
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
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
6 secondary outcomes
body composition (and changes in it in one year period)
Time frame: 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
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
Four square step test: its change as a result of physiotherapy and change over time
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
Tinetti test: its change as a result of physiotherapy and change over time
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
Range of motion: its change as a result of physiotherapy and change over time
Time frame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Assessment of handwriting:its change as a result of physiotherapy and change over time
Time frame: it was assessed during three assessments: at baseline, during second assessment ten weeks later, third assessment was carried out one year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadri Medijainen, MSc principal investigator
Junior research fellow in physiotherapy
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive physical therapy in people with Parkinson Disease, run by University of Tartu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed during transitioning from sitting to walking and its change as a result of physiotherapy and change over time (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568903, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.