Efficacy of a Robotic-assisted Gait Training in Addition to a Conventional Physical Therapy in Parkinson's Disease

NCT02164162 | Unknown DMC

• 1 other identifier: RAR06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In Parkinson's disease, gait disturbances represent one of the most disabling motor symptoms, frequently associated with an increased risk of falls, loss of independence and a negative impact on quality of life. In recent years, the interest in automated robotic devices for gait training for Parkinson's Disease patients has grown. With their consistent, symmetrical lower-limb trajectories, robotic devices provide many of the proprioceptive inputs that may increase cortical activation and improve motor function while minimizing the intervention of a therapist. So the main aim of this study will be to analyze, through a clinical and an instrumental evaluation, the effectiveness of a Lokomat gait training in subjects affected by Parkinson's disease in comparison to a ground conventional gait training.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Lokomat, gait training, rehabilitation.

Outcome Measures

Primary Outcomes (1)

• Timed 6 meter walking test

  Timed 6-meter walking test evaluate the gait speed. Individual walks without assistance 10 meters and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration

  4 weeks

Secondary Outcomes (5)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale Disease rating scale motor sub-scores)

  4 weeks

• Functional Independence Measure

  4 weeks

• Barthel Index

  4 weeks

• Tinetti Test

  4 weeks

• Parkinson's Disease Questionnaire -39 item

  4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants received 12 sessions of robotic assisted body weight-supported treadmill training on the Lokomat. Training occurred approximately 3 days/ week for 4 weeks, and each training session on the Lokomat lasted 30 minutes. All sessions were supervised by a trained research therapist. All participants started with 40% body weight-support and an initial treadmill speed of 1.5 km/h. Body weight-support was used primarily to facilitate an increase in walking speed; therefore, progression of training across subsequent sessions was standardized by preferentially increasing speed and then unloading body weight-support. Speed was increased to a range of 2.2 to 2.5 km/h before body weight-support was decreased. There was an active attempt to enhance the level of training at each session.

Device: Lokomat (Hocoma, Zurich, Switzerland)

Control group

ACTIVE COMPARATOR

Participants received 20 sessions of conventional physiotherapy. Training occurred approximately 5 days/week for 4 weeks, and each training session lasted 1 hour .Patients allocated to the Control Group performed a general exercise program and a conventional gait training with a 5-minute rest between them. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and dual task activities and balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation concept (lasting 30 minutes), with rhythmic initiation, slow reversal, and agonistic reversal exercises applied to the pelvic region, each 10 minutes long.

Other: Conventional physical treatment

Interventions

Lokomat (Hocoma, Zurich, Switzerland) DEVICE

Patients allocated to the Experimental group performed a Robotic Assistested Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat.

Experimental group

Conventional physical treatment OTHER

Patients allocated to the Control Group performed a general exercise program and a conventional gait training. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and dual task activities and balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation (PNF) concept (lasting 30 minutes), with rhythmic initiation, slow reversal, and agonistic reversal exercises applied to the pelvic region, each 10 minutes long. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment.

Also known as: Control group

Control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease stage 2 to 3 (calculated in the "on phase") on the Hoehn and Yahr scale
• independent walking
• clinical-pharmacological stabilization until three months before the beginning of the study.

You may not qualify if:

• deficits of somatic sensation involving the legs
• vestibular disorders or paroxysmal vertigo
• other neurological, orthopedic or cardiovascular co-morbility
• severe posture abnormalities
• severe-moderate cognitive impairment (Minmental state ≤ 21)
• severe dyskinesia or "on-off"phases

Sponsors & Collaborators

• Habilita, Ospedale di Sarnico: lead

Study Sites (1)

Casa di Cura Habilita

Ciserano, Bergamo, 24040, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

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)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

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

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 16, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

IT (1)