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Parkinson DiseaseNCT04921748

Neurorehabilitation of Sequence Effect in Parkinson's Disease

An observational study of Parkinson Disease and Freezing of Gait, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease, Freezing of Gait
What is being tested?
Neurorehabilitation
Type of treatment
Surgery or procedure
How many people
43 participants
Where
1 siteItaly
Study dates
1 Aug 2019to 28 Feb 2021
Phase
Observational
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients affected by Idiopathic Parkinson's disease with and without freezing of gait to be consecutively enroll among those attending the Neurorehabilitation Department of the IRCCS Mondino Foundation (Pavia, Italy)

Who may be able to join

  • Idiopathic Parkinson's disease
  • Hoehn and Yahr stage between I and IV
  • Mini-Mental State Examination score above 24.

Who cannot join

  • Major psychiatric or other neurological conditions,
  • Rheumatological diseases
  • Ophthalmic diseases
  • Orthopedic diseases
  • Ongoing or previous treatment with neuroleptic drugs
  • Patients with deep brain stimulation
  • Any change in dose or regimen of the anti-parkinsonian therapy in the last month before enrolment.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Mondino Foundation

    Pavia, 27100

Other trials in Italy

About this study

Official title: Destination Sequence Effect Modifications After a 4-week Rehabilitation Program in Parkinson's Diseases Patients

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (dSE). The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinson's disease with and without Freezing of Gait. All subjects were evaluated with inertial gait analysis for dSE recording.

Read the detailed description

Gait impairment and freezing of gait (FOG) represent common and disabling symptoms of Parkinson's disease (PD). The antiparkinsonian therapy positively modulates a subset of gait parameters, such as speed of gait and stride length, while its impact on FOG is limited. Growing evidence supports the efficacy of neurorehabilitation in the treatment of PD across all phases of the disease. In the last years, the advent of reliable wearable devices has prompted the widespread study of several parameters of the parkinsonian gait in both clinical and research settings.

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of several tasks of patients affected by PD, being identifiable in early as well as advanced stages of the disease. During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (destination sequence effect - dSE). SE is specifically pronounced in PD patients affected by FOG, and it arises immediately before a FOG episode induced by a turning or a dual-task.

SE may be acutely modulated by several rehabilitative strategies such as split-belt treadmill and reinforcement of visual cues, but not by repetitive transcranial magnetic stimulation (rTMS), antiparkinsonian drugs administration, and attention strategies did not influence the SE, the evidence on the role of neurorehabilitation on gait SE improvement and retention is extremely scarce.

The investigators plan to enroll 43 subjects according to sample size calculation. Patients will be divided into two groups: patients with freezing of gait (FOG) and without FOG. The subjects will be divided into two groups: 1) patients with freezing of gait (PD+FOG), or 2) patients without freezing of gait (PD-FOG). FOG phenotype is defined as: a score between 1 and 4 at either item "2.13 Freezing" or item "3.11 Freezing of gait" of the Unified Parkinson Disease Rating Scale (UPDRS).

All patients will be treated with a standardized 4-week rehabilitation in-hospital program. At hospital admission (T0), patients who fulfill inclusion/exclusion criteria will be tested with instrumental gait analysis and administration of a set of the following clinical scales: rating of PD related motor disability with the Unified Parkinson's Disease Rating Scale - part III (UPDRS-III); rating of functional independence as measured through the Functional Independence Measure (FIM); and rating of dependence in activity of daily living according to Barthel Index.

After that, patients will be treated with 90-minute daily rehabilitative sessions, 6 days a week (Monday through Saturday) for four weeks (passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing). The rehabilitation program will be the same in PD+FOG and PD-FOG groups. At the end of the rehabilitation program (T1), the patients will complete the study procedure with a second instrumental gait analysis evaluation and the administration of the same set of clinical scales. No modifications of the drug regimen were allowed during the study.

The gait analysis will be performed with wearable, wireless, inertial system, secured to the back of the patients between L5 and S1 vertebrae. All subjects will be recorded in the morning (between 9:00 a.m. and 11:00 a.m.) and in the ON condition. The investigators plan to record a walk, at a comfortable pace, of 20 meters. The subjects will stop independently at the end of the 20-meter pathway, clearly marked by a straight line on the ground. Gait assessments with episodes of freezing of gait or pauses will be discrded. For each subject, three optimal performed gait assessments will be recorded. Regarding gait parameters the investigators will record: speed (m/s), cadence (steps/minute), stride length (meter), step length (meter), stride duration (second), single support, double support, swing duration, stance duration (percentage stride distribution). The destination Sequence Effect (dSE) will be computed as a regression slope (β) of step length according to a previously described and validated methodology where step length is plotted against step number. Briefly, the length of the last six steps ahead of the final stride are plotted against the step number, and the linear regression slope (β) will represent a measure of dSE. In addition, the intercept (I) of the regression curve will be used as an indirect measure of gait hypokinesia. For each group, the relationship between gait hypokinesia and sequence effect is expressed by the function of the linear regression as follow: y = β (x) + I.

Being tested
Neurorehabilitation
Keywords
Movement disorders, Gait analysis, Hypokinesia, Basal ganglia, Functional indipendence
Medical subject headings
Parkinson Disease, Movement Disorders, Hypokinesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurorehabilitationProcedure or surgery

    Also called Rehabilitation, Physical therapy

    All patients will be treated with an in-hospital rehabilitation program focused on the rehabilitation of gait disorder in PD with 90-minute daily sessions, 6 days a week (Monday through Saturday) for four weeks. The rehabilitation treatment includes passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program is the same in PD patients with and without FOG.

Study groups in NCT04921748
Study groupRoleWhat they receive
PD+FOG groupPatients affected by Parkinson's Disease with freezing of gait (PD+FOG group)
Receives: Procedure: Neurorehabilitation
PD-FOG groupPatients affected by Parkinson's Disease without freezing of gait (PD+FOG group)
Receives: Procedure: Neurorehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Destination sequence effect (dSE) modifications

    Using an inertial gait analysis we will explore the modifications of destination sequence effect in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

Secondary outcomes (13)
  1. Between-group comparison of dSE

    Comparison of destination Sequence Effect in PD patients with FOG vs. PD patients without FOG

    Measured: Baseline (T0)

  2. Gait hypokinesia modifications

    Using an inertial gait analysis we will explore the modifications of intercept "I" in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  3. Speed modifications

    Using an inertial gait analysis we will explore the modifications of speed (m/s) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  4. Cadence modifications

    Using an inertial gait analysis we will explore the modifications of cadence (steps/min) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  5. Stride duration modifications

    Using an inertial gait analysis we will explore the modifications of stride duration (s) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  6. Stride lenght modifications

    Using an inertial gait analysis we will explore the modifications of stride length (m) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  7. Stance modifications

    Using an inertial gait analysis we will explore the modifications of stance phase (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  8. Swing modifications

    Using an inertial gait analysis we will explore the modifications of Swing phase (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  9. Double support modifications

    Using an inertial gait analysis we will explore the modifications of double support (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  10. Single support modifications

    Using an inertial gait analysis we will explore the modifications of single support (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  11. Motor disability improvement

    We will explore the changes in motor disability as measured by Unified Parkinson Disease Rating Scale - part III (UPDRS-III) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  12. Functional Independence improvement

    We will explore the changes in functional independence as measured by Functional Independence Measure (FIM) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

  13. Dependence in activity of daily living improvement

    We will explore the changes in dependence in activity of daily living as measured by barthel Index in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program

    Measured: Change from baseline (T0) to four weeks (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start1 Aug 2019
  3. Primary completion31 Jan 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921748
Sponsor's protocol ID
Neurorehab in PD
Status last verified
Jun 2021
First submitted
4 Jun 2021
Last updated
15 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kang SY, Wasaka T, Shamim EA, Auh S, Ueki Y, Lopez GJ, Kida T, Jin SH, Dang N, Hallett M. Characteristics of the sequence effect in Parkinson's disease. Mov Disord. 2010 Oct 15;25(13):2148-55. doi: 10.1002/mds.23251.

    PubMed 20669182
  • Cao SS, Yuan XZ, Wang SH, Taximaimaiti R, Wang XP. Transverse Strips Instead of Wearable Laser Lights Alleviate the Sequence Effect Toward a Destination in Parkinson's Disease Patients With Freezing of Gait. Front Neurol. 2020 Aug 12;11:838. doi: 10.3389/fneur.2020.00838. eCollection 2020.

    PubMed 32903360

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Freezing of Gait, run by IRCCS National Neurological Institute "C. Mondino" Foundation 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 7 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: finished, as of the sponsor's last update on 15 Jun 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Destination sequence effect (dSE) modifications (time frame: Change from baseline (T0) to four weeks (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04921748, which also lists 2 linked publications.

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 15 Jun 2021.

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