Parkinson's DiseaseNCT02164162
Efficacy of a Robotic-assisted Gait Training in Addition to a Conventional Physical Therapy in Parkinson's Disease
A study testing Lokomat (Hocoma, Zurich, Switzerland) and Conventional physical treatment in people with Parkinson's Disease, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Lokomat (Hocoma, Zurich, Switzerland) and Conventional physical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Casa di Cura Habilita
Ciserano, Bergamo, 24040
Paola Sabattini, Coordinator, +390354815 ext. 507, paolasabattini@habilita.it
Giovanni Taveggia, MD
About this study
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
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.
Read the detailed 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
- Conditions
- Parkinson's Disease
- Being tested
- Lokomat (Hocoma, Zurich, Switzerland), Conventional physical treatment
- Keywords
- Parkinson's disease, Lokomat, gait training, rehabilitation.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional physical treatmentOther
Also called Control group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional physical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (5)
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
Measured: 4 weeks
Functional Independence Measure
to assess daily activities functional autonomy
Measured: 4 weeks
Barthel Index
to assess the degree of disability
Measured: 4 weeks
Tinetti Test
to assess balance and gait ability and the falls risk
Measured: 4 weeks
Parkinson's Disease Questionnaire -39 item
to assess quality of life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Habilita, Ospedale di Sarnico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Taveggia, Habilita, Ospedale di Sarnico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164162
- Sponsor's protocol ID
- RAR06
- Status last verified
- Jun 2014
- First submitted
- 10 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02164162
- Acronym / sponsor ID
- RAR06
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Lokomat, gait training, rehabilitation.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Habilita, Ospedale di SarnicoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Lokomat (Hocoma, Zurich, Switzerland)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. |
| Control group | Active comparator | Other: Conventional physical treatmentParticipants 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental group |
| Conventional physical treatmentAlso: Control groupPatients 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. | Other | Control group |
Primary outcome
Timed 6 meter walking test
Time frame: 4 weeks
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
5 secondary outcomes
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Disease rating scale motor sub-scores)
Time frame: 4 weeks
Functional Independence Measure
Time frame: 4 weeks
Barthel Index
Time frame: 4 weeks
Tinetti Test
Time frame: 4 weeks
Parkinson's Disease Questionnaire -39 item
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat (Hocoma, Zurich, Switzerland) and Conventional physical treatment in people with Parkinson's Disease, run by Habilita, Ospedale di Sarnico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed 6 meter walking test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.