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Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical therapy
Sponsored by
Universitatea de Medicina si Farmacie Iuliu Hatieganu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group physical therapy

    Individual physical therapy

    Arm Description

    Groups of 6 patients and 1 physical therapist for the 1.5 hour physical therapy session

    1.5 hour physical therapy session 1 on 1 (1 patient and 1 physical therapist)

    Outcomes

    Primary Outcome Measures

    Change in Walking speed (meters/seconds)
    the 6-minute walking test
    Change in Walking speed
    the 10-meter walking test.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2019
    Last Updated
    December 3, 2019
    Sponsor
    Universitatea de Medicina si Farmacie Iuliu Hatieganu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04187963
    Brief Title
    Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease
    Official Title
    Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (Actual)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitatea de Medicina si Farmacie Iuliu Hatieganu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    case-control
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group physical therapy
    Arm Type
    Experimental
    Arm Description
    Groups of 6 patients and 1 physical therapist for the 1.5 hour physical therapy session
    Arm Title
    Individual physical therapy
    Arm Type
    Active Comparator
    Arm Description
    1.5 hour physical therapy session 1 on 1 (1 patient and 1 physical therapist)
    Intervention Type
    Other
    Intervention Name(s)
    Physical therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Walking speed (meters/seconds)
    Description
    the 6-minute walking test
    Time Frame
    at baseline and after 10 days
    Title
    Change in Walking speed
    Description
    the 10-meter walking test.
    Time Frame
    at baseline and after 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease

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