Parkinson DiseaseNCT03346265
Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD
A study testing Treatment A combined exercise program and gait training with sensory cues and Treatment B Conventional physiotherapy in people with Parkinson Disease and Movement Disorders, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
In the present study, the investigators propose a rehabilitative program for Parkinson' disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. Read more about this study
- Who is it for?
- Ages 55 to 76 years
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Treatment A combined exercise program and gait training with sensory cues and Treatment B Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to 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 55 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of idiopathic PD according to UK bank criteria
- Hoehn and Yahr stages 1 to 3.
- United Parkinson Disease Rating Scale (UPDRS) gait subscore of 1 or more, no change in medication during the study period.
- All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks.
Who cannot join
- cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
- moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]),
- orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.
In the present study, the investigators propose a rehabilitative program for Parkinson' disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. The rationale herein was that the RMP may globally improve patients in terms of trunk control, motor performance, muscle tone, endurance and so on, predisposing them to improvement of the gait rhythm and automaticity induced by use of the visual external cues.
The primary aim of this pilot, randomized, controlled, trial with crossover was to establish whether a 8-week exercise program focused at improving gait in people with PD was more effective than a same-duration program of standard physiotherapy. The secondary aim was to evaluate the effect on the disease's severity. At this aims investigators used a quantitative 3D motion analysis system to evaluate gait parameters and UPDRS-II and UPDR-III and H-Y staging to evaluate the severity of the disease.
The investigators hypothesised that the both exercise programs will improve standard physiotherapy, however the proposed program will yield better improvements for the people with PD.
Read the detailed description
This study is a pilot, bi-centric, exploratory, randomized, controlled, crossover design with blind observer .
Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment.
Both clinical (neurological visit and scale administration) and instrumental (gait analysis) assessments were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation). Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase.
Participants were asked to maintain their pre-enrollment activity level and current medication dosage when not in the laboratory.
Assessors, for both clinical and instrumental evaluations, were blinded to the allocation treatment.
During the inactive condition, participants received usual care.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Treatment A combined exercise program and gait training with sensory cues, Treatment B Conventional physiotherapy
- Keywords
- progressive modular rebalancing, PMR, visual sensory cues, SC, Parkinson Disease, Movement Disorders, Parkinson rehabilitation, neurocognitive method, motor performance, improving gait, physiotherapy, 3D motion analysis system, improvements
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A combined exercise program and gait training with sensory cuesOther
Treatment A consisted in a combined exercise program of 40 min duration RMP
Treatment B Conventional physiotherapyOther
Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Treatment A consisted in a combined exercise program of 40 min duration RMP (Monari, 2004; Monari et al., 2016) and 20 min duration of gait training with sensory cues.
RMP. RMP protocol was based on lengthening and muscular recruitment exercises by means of complex motor skills involving muscular kinetic chains in lower limbs and trunk. Each session was divided into muscular stretching exercise, aiming to increase step length and rotating trunk movements, and tailored progressive exercise therapy. Receives: Other: Treatment A combined exercise program and gait training with sensory cues |
| Group B | Experimental | Treatment B Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code): trunk (s760), pelvis (s750), lower extremity (s750), and upper extremity (s730) including shoulder region (s720). Domains focused on were (1) warm-up exercises, (2) trunk mobility exercises, (3) postural stability (b715), and (4) transferring oneself (d420) and changing body positions (d410). Receives: Other: Treatment B Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stance phase duration ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
swing phase duration ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
double support phase duration ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
cadence ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step length normalized for the leg length ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step length asymmetry ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step width ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
mean speed ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
maximal arm displacement on the posterior-anterior axis ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
trunk Range of motion ( change )
Measured: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale
- Part I: evaluation of mentation, behavior, and mood
- Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food
- Part III: clinician-scored monitored motor evaluation
- Part IV: complications of therapy
Measured: were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation)
Hoehn and Yahr
- Unilateral involvement only usually with minimal or no functional disability Unilateral involvement only 1.5 - Unilateral and axial involvement
- Bilateral or midline involvement without impairment of balance Bilateral involvement without impairment of balance 2.5 - Mild bilateral disease with recovery on pull test
- Bilateral disease: mild to moderate disability with impaired postural reflexes; physically independent Mild to moderate bilateral disease; some postural instability; physically independent
- Severely disabling disease; still able to walk or stand unassisted Severe disability; still able to walk or stand unassisted
- Confinement to bed or wheelchair unless aided Wheelchair bound or bedridden unless aided
Measured: were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startMay 2015
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Serrao, University of Roma La Sapienza
- Investigators
- Mariano Serrao, PHD, Principal investigator, Università "La Sapienza di Roma"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346265
- Sponsor's protocol ID
- s002
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.
PubMed 18946880Cassimatis C, Liu KP, Fahey P, Bissett M. The effectiveness of external sensory cues in improving functional performance in individuals with Parkinson's disease: a systematic review with meta-analysis. Int J Rehabil Res. 2016 Sep;39(3):211-8. doi: 10.1097/MRR.0000000000000171.
PubMed 27119224Westwater-Wood S, Adams N, Kerry R (2010): The use of proprioceptive neuromuscular facilitation in physiotherapy practice Physical Therapy Reviews Vol.15 No.1,p23-27
Kabat H, Knapp ME (1943) The use of prostigmine in the treatment of poliomyelitis. JAMA 122: 989-995.
Hove MJ, Keller PE. Impaired movement timing in neurological disorders: rehabilitation and treatment strategies. Ann N Y Acad Sci. 2015 Mar;1337(1):111-7. doi: 10.1111/nyas.12615.
PubMed 25773624Kisner, Carolyn & Colby, Lynn A. (2012):
LEVINE MG, KABAT H. Proprioceptive facilitation of voluntary motion in man. J Nerv Ment Dis. 1953 Mar;117(3):199-211. doi: 10.1097/00005053-195303000-00002. No abstract available.
PubMed 13070034Monari G (2004) FNP, Facilitazioni Neurocinetiche Progressive. Elaborazione del concetto Kabat. Edi Ermes.
Monari G (2013) RMP, Riequilibrio Modulare Progressivo. Elaborazione concetto Kabat. Edi Ermes
Richards CL, Malouin F, Bedard PJ, Cioni M. Changes induced by L-DOPA and sensory cues on the gait of parkinsonian patients In: Woollacott M, Horak F, editors. Posture and gait: control mechanisms. XIth International Symposium of the Society for Postural and Gait Research, Portland, May 24-27, 1992. University of Oregon Books; 1992, p. 126-129.
Marek SM, Cramer JT, Fincher AL, Massey LL, Dangelmaier SM, Purkayastha S, Fitz KA, Culbertson JY. Acute Effects of Static and Proprioceptive Neuromuscular Facilitation Stretching on Muscle Strength and Power Output. J Athl Train. 2005 Jun;40(2):94-103.
PubMed 15970955Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.
PubMed 17052131McAtee RE, Charland J. Facilitated stretching: assisted and unassisted PNF stretching made easy. 2nd ed. Champaign (IL): Human Kinetics, 1999
Kisner & Colby, p208,(2012)
Kisner & Colby 2012, p208
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.
- ClinicalTrials.gov ID
- NCT03346265
- Acronym / sponsor ID
- s002
- Conditions
- Parkinson Disease, Movement Disorders
- Keywords
- progressive modular rebalancing, PMR, visual sensory cues, SC, Parkinson Disease, Movement Disorders, Parkinson rehabilitation, neurocognitive method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 the present study, the investigators propose a rehabilitative program for Parkinson' disease based on the combination of a neurocognitive method, i.e. visual sensory cues, with a neurophysiological method, i.e. RMP, in a randomized controlled trial with cross-over. The rationale herein was that the RMP may globally improve patients in terms of trunk control, motor performance, muscle tone, endurance and so on, predisposing them to improvement of the gait rhythm and automaticity induced by use of the visual external cues.
The primary aim of this pilot, randomized, controlled, trial with crossover was to establish whether a 8-week exercise program focused at improving gait in people with PD was more effective than a same-duration program of standard physiotherapy. The secondary aim was to evaluate the effect on the disease's severity. At this aims investigators used a quantitative 3D motion analysis system to evaluate gait parameters and UPDRS-II and UPDR-III and H-Y staging to evaluate the severity of the disease.
The investigators hypothesised that the both exercise programs will improve standard physiotherapy, however the proposed program will yield better improvements for the people with PD.
Detailed description
This study is a pilot, bi-centric, exploratory, randomized, controlled, crossover design with blind observer .
Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment.
Both clinical (neurological visit and scale administration) and instrumental (gait analysis) assessments were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation). Medication was kept constant throughout the trial, and all interventions were performed at the same time of day for each patient during ON phase.
Participants were asked to maintain their pre-enrollment activity level and current medication dosage when not in the laboratory.
Assessors, for both clinical and instrumental evaluations, were blinded to the allocation treatment.
During the inactive condition, participants received usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects participated in a baseline assessment session (T0, before rehabilitative treatment), followed by random allocation to 8 weeks of rehabilitative treatments (A or B) (T1), followed by 1 month of inactivity wash out period. Following this wash-out period, patients who received treatment A switched to the treatment B and viceversa. A computerized randomization schedule was generated on the computer and held by an investigator not involved in subject recruitment or assessment.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Treatment A combined exercise program and gait training with sensory cuesTreatment A consisted in a combined exercise program of 40 min duration RMP (Monari, 2004; Monari et al., 2016) and 20 min duration of gait training with sensory cues. RMP. RMP protocol was based on lengthening and muscular recruitment exercises by means of complex motor skills involving muscular kinetic chains in lower limbs and trunk. Each session was divided into muscular stretching exercise, aiming to increase step length and rotating trunk movements, and tailored progressive exercise therapy. |
| Group B | Experimental | Other: Treatment B Conventional physiotherapyTreatment B Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code): trunk (s760), pelvis (s750), lower extremity (s750), and upper extremity (s730) including shoulder region (s720). Domains focused on were (1) warm-up exercises, (2) trunk mobility exercises, (3) postural stability (b715), and (4) transferring oneself (d420) and changing body positions (d410). |
Who may qualify
- Ages
- 55 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of idiopathic PD according to UK bank criteria
- Hoehn and Yahr stages 1 to 3.
- United Parkinson Disease Rating Scale (UPDRS) gait subscore of 1 or more, no change in medication during the study period.
- All patients were in a stable drug program and had adapted to their current medications for at least 2 weeks.
Key exclusion criteria (3 listed)
- cognitive deficits (defined as scores of <26 on the Mini-Mental State Examination [MMSE]),
- moderate or severe depression (defined as scores of >17 on the Beck Depression Inventory [BDI]),
- orthopedic and other gait-influencing diseases such as arthrosis or total hip joint replacement.
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 |
|---|---|---|
| Treatment A combined exercise program and gait training with sensory cuesTreatment A consisted in a combined exercise program of 40 min duration RMP | Other | Group A |
| Treatment B Conventional physiotherapyConventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code) | Other | Group B |
Primary outcome
Stance phase duration ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
swing phase duration ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
double support phase duration ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
cadence ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step length normalized for the leg length ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step length asymmetry ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
step width ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
mean speed ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
maximal arm displacement on the posterior-anterior axis ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
trunk Range of motion ( change )
Time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
2 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation)
Hoehn and Yahr
Time frame: were carried out 3 times: at baseline before rehabilitative treatment (T0), 4 weeks (T1, intermediate evaluation) and 8 weeks after rehabilitative treatments (T2, final evaluation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 18946880Keus SH, Munneke M, Nijkrake MJ, Kwakkel G, Bloem BR. Physical therapy in Parkinson's disease: evolution and future challenges. Mov Disord. 2009 Jan 15;24(1):1-14. doi: 10.1002/mds.22141.
- Background: PubMed 27119224Cassimatis C, Liu KP, Fahey P, Bissett M. The effectiveness of external sensory cues in improving functional performance in individuals with Parkinson's disease: a systematic review with meta-analysis. Int J Rehabil Res. 2016 Sep;39(3):211-8. doi: 10.1097/MRR.0000000000000171.
- BackgroundWestwater-Wood S, Adams N, Kerry R (2010): The use of proprioceptive neuromuscular facilitation in physiotherapy practice Physical Therapy Reviews Vol.15 No.1,p23-27
- BackgroundKabat H, Knapp ME (1943) The use of prostigmine in the treatment of poliomyelitis. JAMA 122: 989-995.
- Background: PubMed 25773624Hove MJ, Keller PE. Impaired movement timing in neurological disorders: rehabilitation and treatment strategies. Ann N Y Acad Sci. 2015 Mar;1337(1):111-7. doi: 10.1111/nyas.12615.
- BackgroundKisner, Carolyn & Colby, Lynn A. (2012):
- Background: PubMed 13070034LEVINE MG, KABAT H. Proprioceptive facilitation of voluntary motion in man. J Nerv Ment Dis. 1953 Mar;117(3):199-211. doi: 10.1097/00005053-195303000-00002. No abstract available.
- BackgroundMonari G (2004) FNP, Facilitazioni Neurocinetiche Progressive. Elaborazione del concetto Kabat. Edi Ermes.
- BackgroundMonari G (2013) RMP, Riequilibrio Modulare Progressivo. Elaborazione concetto Kabat. Edi Ermes
- BackgroundRichards CL, Malouin F, Bedard PJ, Cioni M. Changes induced by L-DOPA and sensory cues on the gait of parkinsonian patients In: Woollacott M, Horak F, editors. Posture and gait: control mechanisms. XIth International Symposium of the Society for Postural and Gait Research, Portland, May 24-27, 1992. University of Oregon Books; 1992, p. 126-129.
- Background: PubMed 15970955Marek SM, Cramer JT, Fincher AL, Massey LL, Dangelmaier SM, Purkayastha S, Fitz KA, Culbertson JY. Acute Effects of Static and Proprioceptive Neuromuscular Facilitation Stretching on Muscle Strength and Power Output. J Athl Train. 2005 Jun;40(2):94-103.
- Background: PubMed 17052131Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.
- 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.
Mariano Serrao, PHD principal investigator
Università "La Sapienza di Roma"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment A combined exercise program and gait training with sensory cues and Treatment B Conventional physiotherapy in people with Parkinson Disease and Movement Disorders, run by University of Roma La Sapienza 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 4 inclusion and 3 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 21 Nov 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?
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?
Stance phase duration ( change ) (time frame: - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments). The study lists 10 primary outcomes in all. 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 NCT03346265, which also lists 22 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 21 Nov 2017.