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Completed

NCT Number: NCT04287023

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Hospital

Cluj-Napoca, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

individual physical therapy

Other

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

Group Physical therapy

Other

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 outcomes

  1. Change in walking speed

    Time frame: at baseline and after 10 days

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

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2021
First posted
Feb 27, 2020
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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