PDTr-T-VRNCT03021408
Effectiveness of Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease
A study testing MIRT + Treadmill, MIRT + Treadmill Plus and MIRT + Virtual Reality in people with PD and Gait Dysfunction, Neurologic, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- PD, Gait Dysfunction, Neurologic, Rehabilitation
- What is being tested?
- MIRT + Treadmill, MIRT + Treadmill Plus and MIRT + Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2017to May 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb, 1999);
- Mild to moderate stage of disease (stage 2-3) according to Hoehn \& Yahr scale;
- Ability to walk on treadmill;
- Visual and hearing capacity sufficient to perceive the cues;
- No cognitive impairment (Mini-Mental State Examination score ≥ 26);
- Stable pharmacological treatment since 2 weeks before admission and during rehabilitation;
Who cannot join
- Diagnosis of atypical or vascular Parkinsonism;
- Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and vestibular disorders which could affect patient's locomotion or balance;
- Neuropsychiatric disturbances;
- Severe dyskinesia;
- Severe freezing of gait;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Moriggia-Pelascini" Hospital
Gravedona Ed Uniti, Como, 22015
Davide Ferrazzoli, MD, +393318643163, davideferrazzoli@gmail.com
Ilaria Zivi, MD, +393805468322
About this study
Official title: Evaluation of the Effectiveness of Three Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease: Treadmill Versus Treadmill-plus Versus Virtual Reality
Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).
Read the detailed description
Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD patients demonstrate reduced stride length and walking speed during free ambulation, while double support duration and cadence rate are increased. Gait disorders are generally poorly responsive to dopaminergic treatments and are related to reduced quality of life and augmented risk of falls. Different rehabilitation techniques based on compensatory and learning strategies, which principally exploit the use of cues to bypass the defective basal ganglia and to ameliorate performance through practice, have been demonstrated to be effective in improving gait in patients with PD. Cueing techniques represent the central core for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that treadmill training can improve gait performance in PD patients. It probably acts as an external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait parameters when compared to treadmill alone. Recently, the application of virtual reality (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the interaction of the person with a virtual environment with the aim to promote motor learning through enhanced perceptions (visual, auditory, and haptic inputs).
It has been widely demonstrated that a multidisciplinary, intensive, goal-based, motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within MIRT.
This study aims at investigating the superiority or the non-inferiority of these different devices in improving gait in PD patients in the context of MIRT.
- Conditions
- PD, Gait Dysfunction, Neurologic, Rehabilitation
- Being tested
- MIRT + Treadmill, MIRT + Treadmill Plus, MIRT + Virtual Reality
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRT + TreadmillOther
PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.
MIRT + Treadmill PlusOther
PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.
MIRT + Virtual RealityOther
PD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MIRT + Treadmill | Experimental | In the context of MIRT, the gait training in this group will be performed by using a treadmill without cues. Receives: Other: MIRT + Treadmill |
| MIRT + Treadmill Plus | Experimental | In the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues. Receives: Other: MIRT + Treadmill Plus |
| MIRT + Virtual Reality | Experimental | In the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs). Receives: Other: MIRT + Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking test (6MWT)
Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium. Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible. No encouragement is offered during the test and no cues are used.
Measured: 4 weeks
Secondary outcomes (3)
Average length of right and left steps
The average length of right and left steps (expressed in centimetres and calculated by averaging the length of all the right steps and left steps, respectively).
Measured: 4 weeks
Coefficient of variance
coefficient of variance (CoV) of both right and left steps (which expresses the amount of variation occurring between footfalls).
Measured: 4 weeks
Step cycle
Step cycle (cycle/s), calculated by averaging the step cycles during the exercise.
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 posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frazzitta Giuseppe, MD, Study director, "Moriggia-Pelascini" Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021408
- Sponsor's protocol ID
- OGZonaMP-PD Gait Rehab
- Acronym
- Tr-T-VR
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Three Different Approaches for the Rehabilitation of Gait in Patients With Parkinson's Disease: Treadmill Versus Treadmill-plus Versus Virtual Reality
- ClinicalTrials.gov ID
- NCT03021408
- Acronym / sponsor ID
- Tr-T-VR / OGZonaMP-PD Gait Rehab
- Conditions
- PD, Gait Dysfunction, Neurologic, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 13 Jan 2017 (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.
Evaluation of the effectiveness of three different approaches for the rehabilitation of gait in patients with PD within a multidisciplinary, intensive rehabilitation treatment (MIRT).
Detailed description
Gait disorders represent one of principal hallmark of Parkinson's disease (PD). Typically, PD patients demonstrate reduced stride length and walking speed during free ambulation, while double support duration and cadence rate are increased. Gait disorders are generally poorly responsive to dopaminergic treatments and are related to reduced quality of life and augmented risk of falls. Different rehabilitation techniques based on compensatory and learning strategies, which principally exploit the use of cues to bypass the defective basal ganglia and to ameliorate performance through practice, have been demonstrated to be effective in improving gait in patients with PD. Cueing techniques represent the central core for the rehabilitation of parkinsonian gait. In this context, it has been demonstrated that treadmill training can improve gait performance in PD patients. It probably acts as an external cue exerting a normalizing effect on the spatiotemporal gait parameters and leading to an enhanced gait rhythmicity and a reduced gait variability. The use of a treadmill with visual and auditory cues (treadmill-plus) seems to lead to a better improvement in gait parameters when compared to treadmill alone. Recently, the application of virtual reality (VR) has been introduced in the rehabilitation of PD. The use of VR is based on the interaction of the person with a virtual environment with the aim to promote motor learning through enhanced perceptions (visual, auditory, and haptic inputs).
It has been widely demonstrated that a multidisciplinary, intensive, goal-based, motor-cognitive and aerobic treatment (MIRT), specifically designed for PD patients, provide parkinsonians with motor and functional benefits. Nevertheless, the contribution provided by treadmill, treadmill-plus and VR on gait parameters has not been previously addressed within MIRT.
This study aims at investigating the superiority or the non-inferiority of these different devices in improving gait in PD patients in the context of MIRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIRT + Treadmill | Experimental | Other: MIRT + TreadmillIn the context of MIRT, the gait training in this group will be performed by using a treadmill without cues. |
| MIRT + Treadmill Plus | Experimental | Other: MIRT + Treadmill PlusIn the context of MIRT, the gait training in this group will be performed by using a treadmill with visual and auditory cues. |
| MIRT + Virtual Reality | Experimental | Other: MIRT + Virtual RealityIn the context of MIRT, the gait training in this group will be performed by using Virtual Reality with enhanced perceptions (visual, auditory, and haptic inputs). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of "probable" idiopathic Parkinson's disease according to Gelb et al (Gelb, 1999);
- Mild to moderate stage of disease (stage 2-3) according to Hoehn \& Yahr scale;
- Ability to walk on treadmill;
- Visual and hearing capacity sufficient to perceive the cues;
- No cognitive impairment (Mini-Mental State Examination score ≥ 26);
Key exclusion criteria (5 listed)
- Diagnosis of atypical or vascular Parkinsonism;
- Occurrence of cardiovascular, orthopaedic, peripheral nerves, musculoskeletal and vestibular disorders which could affect patient's locomotion or balance;
- Neuropsychiatric disturbances;
- Severe dyskinesia;
- Severe freezing of gait;
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 |
|---|---|---|
| MIRT + TreadmillPD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks. | Other | MIRT + Treadmill |
| MIRT + Treadmill PlusPD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks. | Other | MIRT + Treadmill Plus |
| MIRT + Virtual RealityPD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks. | Other | MIRT + Virtual Reality |
Primary outcome
6-minute walking test (6MWT)
Time frame: 4 weeks
Patient is first familiarized with the test by letting him/her go once forward and backward along a straight 15-m line on the ground in a gymnasium. Then, after 15 minutes rest, he/she is instructed to walk from end to end of the line for 6 minutes and to cover as much distance as possible. No encouragement is offered during the test and no cues are used.
3 secondary outcomes
Average length of right and left steps
Time frame: 4 weeks
Coefficient of variance
Time frame: 4 weeks
Step cycle
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 13 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Frazzitta Giuseppe, MD study director
"Moriggia-Pelascini" Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRT + Treadmill, MIRT + Treadmill Plus and MIRT + Virtual Reality in people with PD and Gait Dysfunction, Neurologic, run by Ospedale Generale Di Zona Moriggia-Pelascini 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 6 inclusion and 5 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 13 Jan 2017. 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?
Contact Davide Ferrazzoli, MD (+393318643163, davideferrazzoli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking test (6MWT) (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 13 Jan 2017.