Upper Limb Rehabilitation in People With Parkinson's Disease:

NCT06906679 | Recruiting DMC

• 1 other identifier: RP 12/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effectiveness of upper limb rehabilitation using an end-effector robotic device with exercises designed to improve movements, strength, and coordination of the shoulder, elbow, and wrist in patients with Parkinson's disease who have mild to moderate disability, compared to conventional rehabilitation treatment. The study protocol will involve individuals diagnosed with PD according to the UK Parkinson's Disease Society Brain Bank criteria, who will be randomly assigned to one of the following groups: A - Experimental Group (EG) - robotic treatment for upper limb rehabilitation. B - Control Group (CG) - conventional treatment for upper limb rehabilitation. Secondary objectives include: \- Evaluating the effectiveness of an end-effector robotic system in terms of improving upper limb coordination and functionality through the ARAT test and the UPDRS. Identifying subgroups of participants who may benefit more from robotic therapy based on PD disease stage (Hoehn \& Yahr), age, and upper limb impairment. Analyzing the effects of robotic rehabilitation on quality of life. Assessing participants' compliance and satisfaction levels with the robotic system in terms of improving participation in upper limb rehabilitation.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Upper limb; Rehabilitation; Robotic-assisted therapy; Activities of Daily Living (ADL); Quality of life

Outcome Measures

Primary Outcomes (1)

• Box and Block Test (BBT)

  Box and Blocks test, BBT, is used to measure a manual dexterity that requires repeatedly moving 1-inch blocks from one side of a box to another in 60 seconds. In Box and Blocks test there are test box with 150 blocks and a partition in the middle is placed lengthwise along the edge of a standard-height table. The test taker is instructed to quickly pick up one block at a time with his or her right or left hand. Then carry the box over the partitioned and drop it and it is important for the patient to know that each successful execution is one point and he or she carries two it will be counted as one. The number of blocks that the test taker successfully transferred will becomes the final score and the higher the score the better the gross manual dexterity of the test taker.

  Day 0 (T0 - baseline), day 50 (T1 - After treatment).

Secondary Outcomes (5)

• Action Research Arm Test (ARAT)

  Day 0 (T0 - baseline), day 50 (T1 - After treatment).

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Day 0 (T0 - baseline), day 50 (T1 - After treatment).

• Disabilities of the Arm, Shoulder and Hand (DASH)

  Day 0 (T0 - baseline), day 50 (T1 - After treatment), day 140 (FU1 - 3 months after treatment Follow-Up)

• Client satisfaction questionnaire

  Day 50 (T1 - After treatment).

• System Usability Scale (SUS)

  Day 50 (T1 - After treatment).

Other Outcomes (6)

• Montreal Cognitive Assessment (MoCA)

  Day 0 (T0 - baseline)

• Nine Hole Peg Test

  Day 0 (T0 - baseline), day 50 (T1 - After treatment).

• Trail Making Test

  Day 0 (T0 - baseline), day 50 (T1 - After treatment).

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

Participants assigned to Experimental Group (EG) will follow 20 sessions (3 times/week) of robotic-assisted treatment for upper limb rehabilitation using the Motore (Humanware S.r.l, Pisa, Italia ) robotic device in addition to the standard rehabilitation program.

Device: Experimental Group

Control Group (CG)

ACTIVE COMPARATOR

Participants assigned to Control Group (CG) will follow 20 sessions (3 times/week) of conventional tratment for upper limb rehabilitation in addition to the standard rehabilitation program.

Other: control group

Interventions

Experimental Group DEVICE

The EG will follow 20 sessions of robot-assisted therapy for the upper limb. Exercises will be performed using a handpiece to support the weight of the upper limb during therapy and to assist (or resist) movements according to the patient's needs. These modalities are presented to the patient through visual and motor feedback (force feedback). The exercises will focus on rehabilitating upper limb performance, for example: Elbow: flexion-extension; Shoulder: horizontal adduction/abduction, flexion-extension. The software includes serious games for: * Motor control (both movement control and force control); * Coordination; * Cognitive training; * Simulation of daily activities. The exercises will be defined by specialized personnel based on the patient's characteristics. Each rehabilitation session lasts 45 minutes, including 5 minutes for device setup, 20 minutes for the right upper limb and 20 minutes for the left upper limb.

Experimental Group (EG)

control group OTHER

The CG will last 20 sessions (3 days/week) of conventional rehabilitative treatment without the use of technological devices for the upper limb. Each session will last 45 minutes. The motor exercises will focus on upper limb rehabilitation and will be performed with a therapist who will personalize the treatment based on the patient's characteristics and needs. Specifically, the upper limb treatment will include exercises for mobility (shoulder, elbow, wrist, and hand), coordination, and manual dexterity.

Control Group (CG)

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 30 and 80 years;
• Diagnosis of Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria;
• Hoehn \& Yahr scale score between 2 and 3 in the "ON" phase;
• Montreal Cognitive Assessment (MoCA) screening test with a score ≥ 17.54;
• Stable pharmacological therapy for at least 4 weeks and throughout the treatment;
• Ability to understand and sign the informed consent for the study;
• Signed informed consent for the study;
• Ability to comply with the study procedures.

You may not qualify if:

• Unable to adhere to the exercise program due to poor compliance;
• Neurological disorders overlapping with Parkinson's disease, psychiatric complications, or personality disorders;
• Presence of osteoarticular and neuromuscular diseases that may impair upper limb mobility;
• Participants who have not signed the informed consent for the study.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Ministry of Health, Italy: collaborator

Study Sites (2)

San Raffaele Cassino

Cassino, FR, 03043, Italy

NOT YET RECRUITING

IRCCS San Raffaele Roma

Rome, Lazio, 00163, Italy

RECRUITING

Related Publications (15)

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

  PMID: 30879893 BACKGROUND

• Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.

  PMID: 30584159 BACKGROUND

• Tolosa E, Garrido A, Scholz SW, Poewe W. Challenges in the diagnosis of Parkinson's disease. Lancet Neurol. 2021 May;20(5):385-397. doi: 10.1016/S1474-4422(21)00030-2.

  PMID: 33894193 BACKGROUND

• Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.

  PMID: 18344392 BACKGROUND

• Ponsen MM, Daffertshofer A, Wolters ECh, Beek PJ, Berendse HW. Impairment of complex upper limb motor function in de novo Parkinson's disease. Parkinsonism Relat Disord. 2008;14(3):199-204. doi: 10.1016/j.parkreldis.2007.07.019. Epub 2007 Oct 2.

  PMID: 17913560 BACKGROUND

• Quinn L, Busse M, Dal Bello-Haas V. Management of upper extremity dysfunction in people with Parkinson disease and Huntington disease: facilitating outcomes across the disease lifespan. J Hand Ther. 2013 Apr-Jun;26(2):148-54; quiz 155. doi: 10.1016/j.jht.2012.11.001. Epub 2012 Dec 8.

  PMID: 23231827 BACKGROUND

• FITTS PM. The information capacity of the human motor system in controlling the amplitude of movement. J Exp Psychol. 1954 Jun;47(6):381-91. No abstract available.

  PMID: 13174710 BACKGROUND

• Sanes JN. Information processing deficits in Parkinson's disease during movement. Neuropsychologia. 1985;23(3):381-92. doi: 10.1016/0028-3932(85)90024-7.

  PMID: 4022305 BACKGROUND

• Jankovic J, Aguilar LG. Current approaches to the treatment of Parkinson's disease. Neuropsychiatr Dis Treat. 2008 Aug;4(4):743-57. doi: 10.2147/ndt.s2006.

  PMID: 19043519 BACKGROUND

• Peall KJ, Kuiper A, de Koning TJ, Tijssen MA. Non-motor symptoms in genetically defined dystonia: Homogenous groups require systematic assessment. Parkinsonism Relat Disord. 2015 Sep;21(9):1031-40. doi: 10.1016/j.parkreldis.2015.07.003. Epub 2015 Jul 17.

  PMID: 26210889 BACKGROUND

• Grazina R, Massano J. Physical exercise and Parkinson's disease: influence on symptoms, disease course and prevention. Rev Neurosci. 2013;24(2):139-52. doi: 10.1515/revneuro-2012-0087.

  PMID: 23492553 BACKGROUND

• Capecci M, Pournajaf S, Galafate D, Sale P, Le Pera D, Goffredo M, De Pandis MF, Andrenelli E, Pennacchioni M, Ceravolo MG, Franceschini M. Clinical effects of robot-assisted gait training and treadmill training for Parkinson's disease. A randomized controlled trial. Ann Phys Rehabil Med. 2019 Sep;62(5):303-312. doi: 10.1016/j.rehab.2019.06.016. Epub 2019 Aug 1.

  PMID: 31377382 BACKGROUND

• Keus SHJ, Munneke M, Graziano M, et al. European Physiotherapy Guideline for Parkinson's disease. s.l. : KNGF/ParkinsonNet, 2014.

  BACKGROUND

• Vercruysse S, Gilat M, Shine JM, Heremans E, Lewis S, Nieuwboer A. Freezing beyond gait in Parkinson's disease: a review of current neurobehavioral evidence. Neurosci Biobehav Rev. 2014 Jun;43:213-27. doi: 10.1016/j.neubiorev.2014.04.010. Epub 2014 Apr 23.

  PMID: 24769288 BACKGROUND

• Molteni F, Gasperini G, Cannaviello G, Guanziroli E. Exoskeleton and End-Effector Robots for Upper and Lower Limbs Rehabilitation: Narrative Review. PM R. 2018 Sep;10(9 Suppl 2):S174-S188. doi: 10.1016/j.pmrj.2018.06.005.

  PMID: 30269804 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  STUDY CHAIR

• Prof. Marco Franceschini, MD

  IRCCS San Raffaele Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Sanaz Pournajaf, DPT

CONTACT

+39 0652252405; sanaz.pournajfa@sanraffaele.it

Dr. Carrie Louise Thouant, OT

CONTACT

carrielouise.thouant@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: December 20, 2023
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

IT (2)