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

Parkinson's Disease Clinical Trial

Official title:

Interventional Double Blinded Randomized and Controlled Trial on the Efficacy of a Robotic-assisted Gait Training in Addition to a Conventional Physical Therapy in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164162
• Other study ID #: RAR06
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2014
• Last updated: June 20, 2014
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: Habilita, Ospedale di Sarnico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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. Patients with Parkinson's Disease, display an abnormal gait pattern (reduced gait speed, shortened stride length, and a longer double-limb support phase) and they are typically unable to generate a proper stride length and to maintain a steady gait rhythm. Therefore, improving gait ability is a primary goal of physical therapy in patients with Parkinson's Disease. Conventional Physiotherapy aimed at enabling patients to maintain their maximum level of activity and independence is often prescribed, but treatments for gait give only limited benefits. Promising reports have suggested that external sensory cueing (acoustic, visual, verbal cues), through an attention mechanism, may help to increase the deficient internal cueing in Parkinson's Disease, thus improving gait pattern.Treadmill training, which induces a constant horizontal movement, generates a rhythmic input for locomotion, coordinating the upper and lower limbs, offering a useful retraining modality that complements conventional therapy. In the last decade some researchers focused on the use of partial body weight support systems on the ground or with the combination of treadmill training (Body weight support-treadmill). These systems, which improves the ability to stand in an upright position with a redistribution of forces on the trunk, thus disengaging the girdle and upper limbs, suggests a greater improvement in motor performance and walking ability compared with conventional phisiotherapy. 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. Moreover, proprioceptive inputs may share mechanisms that are common to external cues, thus stimulating the cerebellar-premotor pathway to improve gait. Besides,the preprogrammed walking pattern corresponds to normal gait kinematics including: gait cycle timing, inter-limb and inter-joint coordination, appropriate limb loading, and afferent signaling. A recent randomized controlled trial that compared a comprehensive rehabilitative program vis-à-vis robot-assisted gait training has shown that the latter displays some advantages. A pilot, non-controlled study explored the effect of robot-assisted gait training on freezing of gait.Still, despite recent interest in automated locomotion training, there is still very little evidence to support the superiority of this technique over traditional gait training. A computerized gait analysis represents an useful aid to study gait disturbances. The analysis sets objectives and defines quantitative data about gait changes occurred in a patient, in relation to the progression of underlying disease or th effectiveness of treatments administered (medication, surgery or physical). 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Lokomat (Hocoma, Zurich, Switzerland)
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.

Other:
• Conventional physical treatment
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.

Locations

Country	Name	City	State
Italy	Casa di Cura Habilita	Ciserano	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Habilita, Ospedale di Sarnico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Movement Disorder Society-Unified Parkinson's Disease Rating Scale Disease rating scale motor sub-scores)	a scale to assess the motor specific examination for Parkinson's Disease	4 weeks	No
Secondary	Functional Independence Measure	to assess daily activities functional autonomy	4 weeks	No
Secondary	Barthel Index	to assess the degree of disability	4 weeks	No
Secondary	Tinetti Test	to assess balance and gait ability and the falls risk	4 weeks	No
Secondary	Parkinson's Disease Questionnaire -39 item	to assess quality of life	4 weeks	No