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

NCT04287023 | Completed DMC

• 1 other identifier: UniversitateaMFHCluj
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in walking speed

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

  at baseline and after 10 days

Study Arms (2)

Group Physical therapy

EXPERIMENTAL

1 physical therapists and groups of 10 patients during the sessions

Other: group physical therapy

Individual physical therapy

ACTIVE COMPARATOR

1 physical therapist and 1 patient during the sessions

Other: individual physical therapy

Interventions

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

Individual physical therapy

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

Group Physical therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Rehabilitation Hospital

Cluj-Napoca, Romania

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Viorela Ciortea

  Rehabilitation Hospital Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: March 27, 2018
• Primary Completion: May 27, 2018
• Study Completion: March 27, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)