Parkinson DiseaseNCT04187963
Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease
A study testing Physical therapy in people with Parkinson Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy.
Trial summary
Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable medication usage;
- Hoehn and Yahr stage 2, 3 or 4;
- ability to walk independently or by using an assistive walking device;
- age 50 to 70 years;
- no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24);
- no other severe neurologic, cardiopulmonary or orthopedic disorders;
- not having participated in a PT or rehabilitation program in the previous 2 months.
Who cannot join
- not stable medication usage;
- Hoehn and Yahr stage 1;
- inability to walk independently or by using an assistive walking device;
- age less than 50 and more than 70 years;
- severe cognitive impairments (Mini-Mental State Examination - MMSE score, below 24);
- other severe neurologic, cardiopulmonary or orthopedic disorders;
- having participated in a PT or rehabilitation program in the previous 2 months.
About this study
Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Physical therapy interventions are an important part of the non-pharmacological treatment for Parkinson disease. The purpose of this study was to assess whether there is a different outcome regarding improvement of walking speed, when applying a physical therapy program in an individual or in a group manner.
A prospective, observational, cohort type study on 60 patients with Parkinson disease was carried out between November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients were randomly divided into 2 groups, and were prescribed either individual (1 patient and 1 physical therapist) or group physical therapy (6 patients and 1 physical therapist). Treatment protocol included 10 sessions of physical therapy, in the same room setting and performed the same routine of exercises, except for the 3 breaks during the sessions in the group therapy for informal socialization. Walking speed was measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment.
Patients with PD could benefit more from a group physical therapy program, as gait speed increased significantly. The group approach facilitates interactions and is cost-effective, as it requires only one therapist and more patients.
Read the detailed description
The current study was carried out during November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. A total of 60 subjects diagnosed with typical, idiopathic PD participated in this study.
All patients met the following inclusion criteria: (1) stable medication usage; (2) Hoehn and Yahr stage 2, 3 or 4; (3) ability to walk independently or by using an assistive walking device; (4) age 50 to 70 years; (5) no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24); (6) no other severe neurologic, cardiopulmonary or orthopedic disorders; and (7) not having participated in a PT or rehabilitation program in the previous 2 months.
The patients were randomly divided into 2 treatment groups: group physical therapy -GPT (n=30) and individual physical therapy - IPT (n=30).
Treatment protocol for each group included 10 sessions of physical therapy, each 1.5 hour long, on a daily basis for 2 weeks. All treatment sessions occurred at the same time of day throughout the study, in the morning, 60-90 minutes after intake of pharmaceutical treatment for PD. For the GPT, there were groups of 6 patients, supervised by 1 physical therapist. The group sizes were kept small to promote efficiency and motivation. The patients undertaking IPT were alone with the physical therapist during the sessions. Both groups had their encounters in the same physical therapy room setting.
The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.
Also, both groups had access to external cues, which were applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances. There is evidence in the literature to support each of the components contained in the intervention.19-25 In order to facilitate initiation and speed of movement, most activities employed visual and auditory cues as triggers. Visual cues were looking at and follow the therapist's movements in the IPT group or the other group member's movements in the GPT group. A mirror was also used. Auditory cues were music with regular rhythm, and verbal suggestions and reinforcement from the therapist, in the IPT group or the therapist and other participants, in the GPT group.
All patients were evaluated at the beginning and at the end of the physical therapy program. The evaluation included the 6-minute walking test and the 10-meter walking test. Gait speed for each participant was calculated as the ratio between the walked distance and the time unit, and it was measured in meters/seconds.
For each subject, all assessment sessions were performed in the morning, by the same person and all tests were performed in the same order, to control for variations in performance because of medication cycle. All assessments were conducted in the "on" state for the subjects experiencing motor fluctuations.
- Conditions
- Parkinson Disease
- Being tested
- Physical 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.
Physical therapyOther
The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.
Also, both groups had access to external cues, which were applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances.
| Study group | Role | What they receive |
|---|---|---|
| Group physical therapy | Experimental | Groups of 6 patients and 1 physical therapist for the 1.5 hour physical therapy session Receives: Other: Physical therapy |
| Individual physical therapy | Active comparator | 1.5 hour physical therapy session 1 on 1 (1 patient and 1 physical therapist) Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking speed (meters/seconds)
the 6-minute walking test
Measured: at baseline and after 10 days
Change in Walking speed
the 10-meter walking test.
Measured: at baseline and after 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study startNov 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- case-control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciubean Alina Deniza, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187963
- Sponsor's protocol ID
- UniversitateaMFHCluj
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04187963
- Acronym / sponsor ID
- UniversitateaMFHCluj
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Dec 2019 (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.
Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Physical therapy interventions are an important part of the non-pharmacological treatment for Parkinson disease. The purpose of this study was to assess whether there is a different outcome regarding improvement of walking speed, when applying a physical therapy program in an individual or in a group manner.
A prospective, observational, cohort type study on 60 patients with Parkinson disease was carried out between November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients were randomly divided into 2 groups, and were prescribed either individual (1 patient and 1 physical therapist) or group physical therapy (6 patients and 1 physical therapist). Treatment protocol included 10 sessions of physical therapy, in the same room setting and performed the same routine of exercises, except for the 3 breaks during the sessions in the group therapy for informal socialization. Walking speed was measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment.
Patients with PD could benefit more from a group physical therapy program, as gait speed increased significantly. The group approach facilitates interactions and is cost-effective, as it requires only one therapist and more patients.
Detailed description
The current study was carried out during November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. A total of 60 subjects diagnosed with typical, idiopathic PD participated in this study.
All patients met the following inclusion criteria: (1) stable medication usage; (2) Hoehn and Yahr stage 2, 3 or 4; (3) ability to walk independently or by using an assistive walking device; (4) age 50 to 70 years; (5) no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24); (6) no other severe neurologic, cardiopulmonary or orthopedic disorders; and (7) not having participated in a PT or rehabilitation program in the previous 2 months.
The patients were randomly divided into 2 treatment groups: group physical therapy -GPT (n=30) and individual physical therapy - IPT (n=30).
Treatment protocol for each group included 10 sessions of physical therapy, each 1.5 hour long, on a daily basis for 2 weeks. All treatment sessions occurred at the same time of day throughout the study, in the morning, 60-90 minutes after intake of pharmaceutical treatment for PD. For the GPT, there were groups of 6 patients, supervised by 1 physical therapist. The group sizes were kept small to promote efficiency and motivation. The patients undertaking IPT were alone with the physical therapist during the sessions. Both groups had their encounters in the same physical therapy room setting.
The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.
Also, both groups had access to external cues, which were applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances. There is evidence in the literature to support each of the components contained in the intervention.19-25 In order to facilitate initiation and speed of movement, most activities employed visual and auditory cues as triggers. Visual cues were looking at and follow the therapist's movements in the IPT group or the other group member's movements in the GPT group. A mirror was also used. Auditory cues were music with regular rhythm, and verbal suggestions and reinforcement from the therapist, in the IPT group or the therapist and other participants, in the GPT group.
All patients were evaluated at the beginning and at the end of the physical therapy program. The evaluation included the 6-minute walking test and the 10-meter walking test. Gait speed for each participant was calculated as the ratio between the walked distance and the time unit, and it was measured in meters/seconds.
For each subject, all assessment sessions were performed in the morning, by the same person and all tests were performed in the same order, to control for variations in performance because of medication cycle. All assessments were conducted in the "on" state for the subjects experiencing motor fluctuations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- case-control
| Arm | Type | Receives |
|---|---|---|
| Group physical therapy | Experimental | Other: Physical therapyGroups of 6 patients and 1 physical therapist for the 1.5 hour physical therapy session |
| Individual physical therapy | Active comparator | Other: Physical therapy1.5 hour physical therapy session 1 on 1 (1 patient and 1 physical therapist) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- stable medication usage;
- Hoehn and Yahr stage 2, 3 or 4;
- ability to walk independently or by using an assistive walking device;
- age 50 to 70 years;
- no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24);
Key exclusion criteria (7 listed)
- not stable medication usage;
- Hoehn and Yahr stage 1;
- inability to walk independently or by using an assistive walking device;
- age less than 50 and more than 70 years;
- severe cognitive impairments (Mini-Mental State Examination - MMSE score, below 24);
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 |
|---|---|---|
| Physical therapyThe rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session. Also, both groups had access to external cues, which were applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances. | Other | Group physical therapy, Individual physical therapy |
Primary outcome
Change in Walking speed (meters/seconds)
Time frame: at baseline and after 10 days
the 6-minute walking test
Change in Walking speed
Time frame: at baseline and after 10 days
the 10-meter walking test.
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 5 Dec 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Parkinson Disease, run by Iuliu Hatieganu University of Medicine and Pharmacy.
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 7 inclusion and 7 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 5 Dec 2019. 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?
Change in Walking speed (meters/seconds) (time frame: at baseline and after 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2019.