Clinical trial NCT04287023: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in walking speed
timeFrame: at baseline and after 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Rehabilitation Hospital
Study officials:
affiliation: Rehabilitation Hospital Cluj-Napoca
name: Viorela Ciortea
role: PRINCIPAL_INVESTIGATOR
References: