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Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
individual physical therapy
group physical therapy
Sponsored by
Iuliu Hatieganu University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, 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;
  • 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;
  • 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

  • Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Physical therapy

Individual physical therapy

Arm Description

1 physical therapists and groups of 10 patients during the sessions

1 physical therapist and 1 patient during the sessions

Outcomes

Primary Outcome Measures

Change in walking speed
meters/seconds - the 6 minute walk test and 10 meter walk test

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
May 31, 2021
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT04287023
Brief Title
Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease
Official Title
Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
May 27, 2018 (Actual)
Study Completion Date
March 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy

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 is to assess whether there is a different outcome regarding improvement of gait parameters, when applying a physical therapy program in an individual or in a group manner. The study setting is the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients will be 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 includes 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 will be measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment.
Detailed Description
The rehabilitation protocol for the individual physical therapy will consist of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the group protocol will follow 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 will have access to external cues, which will be 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. All patients will be evaluated at the beginning and at the end of the physical therapy program. The evaluation includes the 6-minute walking test and the 10-meter walking test. Gait speed for each participant will be calculated as the ratio between the walked distance and the time unit, and it was measured in meters/seconds.

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
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Physical therapy
Arm Type
Experimental
Arm Description
1 physical therapists and groups of 10 patients during the sessions
Arm Title
Individual physical therapy
Arm Type
Active Comparator
Arm Description
1 physical therapist and 1 patient during the sessions
Intervention Type
Other
Intervention Name(s)
individual physical therapy
Intervention Description
cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - individual
Intervention Type
Other
Intervention Name(s)
group physical therapy
Intervention Description
cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - groups of 10 patients
Primary Outcome Measure Information:
Title
Change in walking speed
Description
meters/seconds - the 6 minute walk test and 10 meter walk test
Time Frame
at baseline and after 10 days

10. Eligibility

Sex
All
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; 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viorela Ciortea
Organizational Affiliation
Rehabilitation Hospital Cluj-Napoca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital
City
Cluj-Napoca
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
upon request

Learn more about this trial

Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease

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