Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD

NCT03346265 | Completed

• 1 other identifier: s002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Movement Disorders

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

Outcome Measures

Primary Outcomes (10)

• Stance phase duration ( change )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• swing phase duration ( change )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• double support phase duration ( change )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• cadence ( change )

  - 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 )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• step length asymmetry ( change )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• step width ( change )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• mean speed ( change )

  - 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 )

  - T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments

• trunk Range of motion ( change )

  - 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

  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

  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)

Study Arms (2)

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.

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).

Other: Treatment B Conventional physiotherapy

Interventions

Treatment A combined exercise program and gait training with sensory cues OTHER

Treatment A consisted in a combined exercise program of 40 min duration RMP

Group A

Treatment B Conventional physiotherapy OTHER

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)

Group B

Eligibility Criteria

• Age: 55 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Italia Srl

Rome, Lazio, 00162, Italy

Location

Related Publications (22)

• 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.

  PMID: 18946880 BACKGROUND

• 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.

  PMID: 27119224 BACKGROUND

• 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

  BACKGROUND

• Kabat H, Knapp ME (1943) The use of prostigmine in the treatment of poliomyelitis. JAMA 122: 989-995.

  BACKGROUND

• 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.

  PMID: 25773624 BACKGROUND

• Kisner, Carolyn & Colby, Lynn A. (2012):

  BACKGROUND

• 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.

  PMID: 13070034 BACKGROUND

• Monari G (2004) FNP, Facilitazioni Neurocinetiche Progressive. Elaborazione del concetto Kabat. Edi Ermes.

  BACKGROUND

• Monari G (2013) RMP, Riequilibrio Modulare Progressivo. Elaborazione concetto Kabat. Edi Ermes

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 15970955 BACKGROUND

• 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.

  PMID: 17052131 BACKGROUND

• McAtee RE, Charland J. Facilitated stretching: assisted and unassisted PNF stretching made easy. 2nd ed. Champaign (IL): Human Kinetics, 1999

  BACKGROUND

• Kisner & Colby, p208,(2012)

  BACKGROUND

• Kisner & Colby 2012, p208

  BACKGROUND

• 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

  BACKGROUND

• Surburg PR, Schrader JW. Proprioceptive neuromuscular facilitation techniques in sports medicine: a reassessment. J Athl Train. 1997 Jan;32(1):34-9.

  PMID: 16558430 BACKGROUND

• 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.

  PMID: 15273211 BACKGROUND

• 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.

  PMID: 17699884 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16489437 BACKGROUND

• 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.

  PMID: 31543859 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mariano Serrao, PHD

  Università "La Sapienza di Roma"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 17, 2017
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)