Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD
NCT ID: NCT03346265
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2015-05-31
2017-05-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Group A
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.
Treatment A combined exercise program and gait training with sensory cues
Treatment A consisted in a combined exercise program of 40 min duration RMP
Group B
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).
Treatment B Conventional physiotherapy
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)
Interventions
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Treatment A combined exercise program and gait training with sensory cues
Treatment A consisted in a combined exercise program of 40 min duration RMP
Treatment B Conventional physiotherapy
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)
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
55 Years
76 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Mariano Serrao
Clinical Professor
Principal Investigators
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Mariano Serrao, PHD
Role: PRINCIPAL_INVESTIGATOR
Università "La Sapienza di Roma"
Locations
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Policlinico Italia Srl
Rome, Lazio, Italy
Countries
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References
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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.
Cassimatis 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.
Westwater-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.
Kisner, 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.
Monari 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.
Sharman 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.
McAtee 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
Nagarwal, A.K., Zutshi K., Ram C.S., Zafar R.(2010). Improvement of hamstring flexibility: A comparison between two PNFstretching techniques. International Journal of Sports Science and Engineering.4 (2010) 1, pp 025-033
Surburg PR, Schrader JW. Proprioceptive neuromuscular facilitation techniques in sports medicine: a reassessment. J Athl Train. 1997 Jan;32(1):34-9.
Feland JB, Marin HN. Effect of submaximal contraction intensity in contract-relax proprioceptive neuromuscular facilitation stretching. Br J Sports Med. 2004 Aug;38(4):E18. doi: 10.1136/bjsm.2003.010967.
Ford P, McChesney J. Duration of maintained hamstring ROM following termination of three stretching protocols. J Sport Rehabil. 2007 Feb;16(1):18-27. doi: 10.1123/jsr.16.1.18.
Nagarwal, A.K., Zutshi K., Ram C.S., Zafar R. (2010). Improvement of hamstring flexibility: A comparison between two PNF stretching techniques. International Journal of Sports Science and Engineering. 4 (2010) 1, pp 025-033.
Kavanagh J, Barrett R, Morrison S. The role of the neck and trunk in facilitating head stability during walking. Exp Brain Res. 2006 Jul;172(4):454-63. doi: 10.1007/s00221-006-0353-6. Epub 2006 Feb 18.
Serrao M, Pierelli F, Sinibaldi E, Chini G, Castiglia SF, Priori M, Gimma D, Sellitto G, Ranavolo A, Conte C, Bartolo M, Monari G. Progressive Modular Rebalancing System and Visual Cueing for Gait Rehabilitation in Parkinson's Disease: A Pilot, Randomized, Controlled Trial With Crossover. Front Neurol. 2019 Aug 29;10:902. doi: 10.3389/fneur.2019.00902. eCollection 2019.
Other Identifiers
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s002
Identifier Type: -
Identifier Source: org_study_id