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

Parkinson Disease Clinical Trial

Official title:

Progressive Modular Rebalancing (RMP) System Rehabilitation Combined With Sensory Cues for Rehabilitation of Patients With PD: a Randomized, Controlled Trial With Crossover.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346265
• Other study ID #: s002
• Status: Completed
• Phase: N/A
• First received: October 24, 2017
• Last updated: November 19, 2017
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Italy	Policlinico Italia Srl	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (21)

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. Review. — View 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. — View 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. — View Citation

Hove MJ, Keller PE. Impaired movement timing in neurological disorders: rehabilitation and treatment strategies. Ann N Y Acad Sci. 2015 Mar;1337:111-7. doi: 10.1111/nyas.12615. Review. — View Citation

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

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. Epub 2006 Feb 18. — View 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. Review. — View Citation

Kisner & Colby 2012, p208

Kisner & Colby, p208,(2012)

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. — View 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. — View Citation

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

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

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.

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

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.

Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. Review. — View Citation

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

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stance phase duration ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	swing phase duration ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	double support phase duration ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	cadence ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	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
Primary	step length asymmetry ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	step width ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	mean speed ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Primary	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
Primary	trunk Range of motion ( change )		- T0 baseline before rehabilitative treatment (T0) - T1 4 weeks (intermediate evaluation) - T2 8 weeks after rehabilitative treatments
Secondary	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	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)
Secondary	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	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)