Effectiveness of a Robotic End-effector Device for Upper Limb Rehabilitation in People With Parkinson's Disease: a Multicenter Randomized Controlled Pilot Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
San Raffaele Cassino
NOT_YET_RECRUITING
Cassino
IRCCS San Raffaele Roma
RECRUITING
Rome
Contact Information
Primary
Dr. Sanaz Pournajaf, DPT
sanaz.pournajfa@sanraffaele.it
+39 0652252405
Backup
Dr. Carrie Louise Thouant, OT
carrielouise.thouant@sanraffaele.it
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 40
Treatments
Experimental: Experimental Group (EG)
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.
Active_comparator: Control Group (CG)
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.
Related Therapeutic Areas
Sponsors
Leads: IRCCS San Raffaele Roma
Collaborators: Ministry of Health, Italy

This content was sourced from clinicaltrials.gov