Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06992700

Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke

Led by University Hospital of Ferrara · Updated on 2025-05-28

52

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

Sponsors

U

University Hospital of Ferrara

Lead Sponsor

U

Università degli Studi di Ferrara

Collaborating Sponsor

AI-Summary

What this Trial Is About

Study procedures: After acquiring clinical-demographic, neurophysiological and clinical-functional data to describe the extent of upper limb impairment at baseline at the facilities of the Rehabilitation Medicine Unit (UMR) of the Ferrara University Hospital (Department of Neuroscience), patients will undergo a 10-day home rehabilitation programme (two consecutive weeks, five days a week, two daily sessions of one hour each) with remote supervision by study staff in a randomised manner in two groups: * Experimental group: patients in this group will perform the exercises at at home with the paretic upper limb wearing the orthosis, © Aurafix, model ORT-07A, characterised by elastic bands that exert resistance on the distal phalanx of the fingers. * Control group: patients in this group will perform the exercises at home with the paretic upper limb wearing the orthosis (in order to stabilise the wrist and eliminate this potential confounding variable) but without the springs that provide resistance (i.e. eliminating the elastic resistance that is the subject of this study); Assignment to the treatment group will be based on a randomisation list (generated through https://www.random.org/ to obtain a balanced division) established by the Scientific Director of the study and communicated exclusively to the personnel involved in administering the treatment sessions, while it will not be disclosed to the personnel involved in the other phases of the study. This will allow for the division of patients and an evaluation of the effectiveness of the treatment between the two groups to be as objective as possible. At the end of the ten days of treatment, patients will return to the facilities of the UMR of the Ferrara University Hospital and repeat the assessments already carried out at baseline, in order to evaluate pre/post performance differences after the home treatment and the differences between the two groups. Finally, questionnaires will be administered to assess fatigue at the end of each day of treatment and patient satisfaction in relation to this telerehabilitation approach at the end of the ten days. It should be noted that patients allocated to the control group will be offered the opportunity to undergo the same treatment as the experimental group, i.e. using the orthosis, in order to ensure that all participants have an equal opportunity to benefit from the innovative protocol. Type of subjects to be enrolled: Subjects diagnosed with chronic cerebral stroke (i.e. at least 6 months after the onset of the acute event) among patients attending the UMR of the Ferrara University Hospital on an outpatient/day-hospital basis for current or previous multidisciplinary rehabilitation treatment specific to the needs of the individual patient. Information/Consent: Each participant will be assessed to determine their preliminary eligibility, informed about the aim and procedures of the study, provided with all necessary information for possible participation in the study and sign the informed consent form. Suspension procedure: At any time during the trial, participants may suspend or withdraw from the study at their own discretion. Breaks during the sessions are also provided for if the participant experiences fatigue, which is the only expected adverse effect, in line with what generally found in any form of repeated physical exercise. Such suspensions will be granted whenever requested, in order to alleviate the participant's discomfort and promote their full participation in the treatment sessions.

CONDITIONS

Official Title

Dynamic Perturbation Training for Home-Based Upper Limb Rehabilitation in Chronic Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 years or older
  • Diagnosis of first cerebral stroke (ischaemic or haemorrhagic) in the chronic phase (at least 6 months after onset) confirmed by brain imaging
  • Motor deficit in the upper limb, especially hand, due to stroke, allowing finger movements and object grasping
  • Ability to provide informed consent
  • Availability of a webcam and Internet connection at home for remote supervision
Not Eligible

You will not qualify if you...

  • Medical conditions interfering with safe completion of the study
  • Cognitive dysfunction preventing informed consent
  • Severe neuropsychological disorders
  • Severe visual problems
  • Upper limb pain with Visual Analogue Scale score greater than 7
  • Severe internal diseases such as cardiopulmonary, renal, or hepatic conditions
  • Inflammatory skin lesions, wounds, sensory or circulatory disorders below the elbow or on the hand in the orthosis area
  • Contraindications to transcranial magnetic stimulation procedures (e.g., intracranial metal implants, epilepsy history, frequent migraines, implantable devices)
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ferrara University Hospital

Ferrara, Emilia-Romagna, Italy, 44124

Actively Recruiting

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Research Team

S

Sofia Straudi, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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