Effects of Group Physical Therapy on Walking Speed in Patients With Parkinson Disease

NCT04187963 | Completed DMC

• 1 other identifier: UniversitateaMFHCluj
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 was to assess whether there is a different outcome regarding improvement of walking speed, when applying a physical therapy program in an individual or in a group manner. A prospective, observational, cohort type study on 60 patients with Parkinson disease was carried out between November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients were 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 included 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 was measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment. Patients with PD could benefit more from a group physical therapy program, as gait speed increased significantly. The group approach facilitates interactions and is cost-effective, as it requires only one therapist and more patients.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change in Walking speed (meters/seconds)

  the 6-minute walking test

  at baseline and after 10 days

• Change in Walking speed

  the 10-meter walking test.

  at baseline and after 10 days

Study Arms (2)

Group physical therapy

EXPERIMENTAL

Groups of 6 patients and 1 physical therapist for the 1.5 hour physical therapy session

Other: Physical therapy

Individual physical therapy

ACTIVE COMPARATOR

1.5 hour physical therapy session 1 on 1 (1 patient and 1 physical therapist)

Other: Physical therapy

Interventions

Physical therapy OTHER

The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed 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 had access to external cues, which were 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.

Group physical therapy; Individual physical therapy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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;
• age 50 to 70 years;
• 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;
• age less than 50 and more than 70 years;
• 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

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 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: Principal investigator

Model Details: case-control

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 5, 2019
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL