Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The current study was carried out during November 2014 - July 2017, in the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. A total of 60 subjects diagnosed with typical, idiopathic PD participated in this study.

All patients met the following inclusion criteria: (1) stable medication usage; (2) Hoehn and Yahr stage 2, 3 or 4; (3) ability to walk independently or by using an assistive walking device; (4) age 50 to 70 years; (5) no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24); (6) no other severe neurologic, cardiopulmonary or orthopedic disorders; and (7) not having participated in a PT or rehabilitation program in the previous 2 months.

The patients were randomly divided into 2 treatment groups: group physical therapy -GPT (n=30) and individual physical therapy - IPT (n=30).

Treatment protocol for each group included 10 sessions of physical therapy, each 1.5 hour long, on a daily basis for 2 weeks. All treatment sessions occurred at the same time of day throughout the study, in the morning, 60-90 minutes after intake of pharmaceutical treatment for PD. For the GPT, there were groups of 6 patients, supervised by 1 physical therapist. The group sizes were kept small to promote efficiency and motivation. The patients undertaking IPT were alone with the physical therapist during the sessions. Both groups had their encounters in the same physical therapy room setting.

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. There is evidence in the literature to support each of the components contained in the intervention.19-25 In order to facilitate initiation and speed of movement, most activities employed visual and auditory cues as triggers. Visual cues were looking at and follow the therapist's movements in the IPT group or the other group member's movements in the GPT group. A mirror was also used. Auditory cues were music with regular rhythm, and verbal suggestions and reinforcement from the therapist, in the IPT group or the therapist and other participants, in the GPT group.

All patients were evaluated at the beginning and at the end of the physical therapy program. The evaluation included the 6-minute walking test and the 10-meter walking test. Gait speed for each participant was calculated as the ratio between the walked distance and the time unit, and it was measured in meters/seconds.

For each subject, all assessment sessions were performed in the morning, by the same person and all tests were performed in the same order, to control for variations in performance because of medication cycle. All assessments were conducted in the "on" state for the subjects experiencing motor fluctuations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04187963
Study type Interventional
Source Universitatea de Medicina si Farmacie Iuliu Hatieganu
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date July 2017

See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A