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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: group physical therapy; Other: individual physical therapy

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj-Napoca, Romania
    • Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking speed	meters/seconds - the 6 minute walk test and 10 meter walk test	at baseline and after 10 days

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Viorela Ciortea, Rehabilitation Hospital Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2018
• Primary Completion (ACTUAL): May 27, 2018
• Study Completion (ACTUAL): March 27, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: UniversitateaMFHCluj

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No