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

Primary Purpose

Parkinson Disease, Movement Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Treatment A combined exercise program and gait training with sensory cues
Treatment B Conventional physiotherapy
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring 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

Eligibility Criteria

55 Years - 76 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Policlinico Italia Srl

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

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 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).

Outcomes

Primary Outcome Measures

Stance phase duration ( change )
swing phase duration ( change )
double support phase duration ( change )
cadence ( change )
step length normalized for the leg length ( change )
step length asymmetry ( change )
step width ( change )
mean speed ( change )
maximal arm displacement on the posterior-anterior axis ( change )
trunk Range of motion ( change )

Secondary Outcome Measures

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
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

Full Information

First Posted
October 24, 2017
Last Updated
November 19, 2017
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT03346265
Brief Title
Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD
Official Title
Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Treatment A combined exercise program and gait training with sensory cues
Intervention Description
Treatment A consisted in a combined exercise program of 40 min duration RMP
Intervention Type
Other
Intervention Name(s)
Treatment B Conventional physiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Stance phase duration ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
swing phase duration ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
double support phase duration ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
cadence ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
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
Title
step length asymmetry ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
step width ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
mean speed ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Title
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
Title
trunk Range of motion ( change )
Time Frame
- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale
Description
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
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)
Title
Hoehn and Yahr
Description
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Serrao, PHD
Organizational Affiliation
Università "La Sapienza di Roma"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Italia Srl
City
Rome
State/Province
Lazio
ZIP/Postal Code
00162
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18946880
Citation
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.
Results Reference
background
PubMed Identifier
27119224
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
Kabat H, Knapp ME (1943) The use of prostigmine in the treatment of poliomyelitis. JAMA 122: 989-995.
Results Reference
background
PubMed Identifier
25773624
Citation
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.
Results Reference
background
Citation
Kisner, Carolyn & Colby, Lynn A. (2012):
Results Reference
background
PubMed Identifier
13070034
Citation
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.
Results Reference
background
Citation
Monari G (2004) FNP, Facilitazioni Neurocinetiche Progressive. Elaborazione del concetto Kabat. Edi Ermes.
Results Reference
background
Citation
Monari G (2013) RMP, Riequilibrio Modulare Progressivo. Elaborazione concetto Kabat. Edi Ermes
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
15970955
Citation
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.
Results Reference
background
PubMed Identifier
17052131
Citation
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.
Results Reference
background
Citation
McAtee RE, Charland J. Facilitated stretching: assisted and unassisted PNF stretching made easy. 2nd ed. Champaign (IL): Human Kinetics, 1999
Results Reference
background
Citation
Kisner & Colby, p208,(2012)
Results Reference
background
Citation
Kisner & Colby 2012, p208
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
16558430
Citation
Surburg PR, Schrader JW. Proprioceptive neuromuscular facilitation techniques in sports medicine: a reassessment. J Athl Train. 1997 Jan;32(1):34-9.
Results Reference
background
PubMed Identifier
15273211
Citation
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.
Results Reference
background
PubMed Identifier
17699884
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
16489437
Citation
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.
Results Reference
background
PubMed Identifier
31543859
Citation
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.
Results Reference
derived

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

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