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

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy (Other)
Overall Status
Completed
CT.gov ID
NCT04287023
Collaborator
(none)
60
1
2
36
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: individual physical therapy
  • Other: group physical therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease
Actual Study Start Date :
Mar 27, 2018
Actual Primary Completion Date :
May 27, 2018
Actual Study Completion Date :
Mar 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group Physical therapy

1 physical therapists and groups of 10 patients during the sessions

Other: group physical therapy
cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - groups of 10 patients

Active Comparator: Individual physical therapy

1 physical therapist and 1 patient during the sessions

Other: individual physical therapy
cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - individual

Outcome Measures

Primary Outcome Measures

  1. Change in walking speed [at baseline and after 10 days]

    meters/seconds - the 6 minute walk test and 10 meter walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rehabilitation Hospital Cluj-Napoca Romania

Sponsors and Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Viorela Ciortea, Rehabilitation Hospital Cluj-Napoca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Viorela Mihaela Ciortea, MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier:
NCT04287023
Other Study ID Numbers:
  • UniversitateaMFHCluj
First Posted:
Feb 27, 2020
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021