Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-30 @ 6:10 AM
Study NCT ID:
NCT02721212
Status:
UNKNOWN
Last Update Posted:
2016-03-29
First Post:
2016-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients.
Sponsor:
Habilita S.p.A.
Organization:
Study Overview
Official Title:
Impact of a New Technology to Functional Recovery Upper Limb in Post Stroke Patients: a Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
54 inpatients participants were randomly divided into two groups (experimental and conventional). Individual of experimental group were treated according to an established protocol for ARMEO Spring (30 minutes/session with "Armeo Spring" and 30 minutes/session with conventional treatment 5 days/week for 6 weeks). The conventional treatment consists of passive and active assisted mobilization of the upper limbs, traditional training based on the Bobath concept. Inpatients of control group were treated with conventional treatment with training session of 60 minutes 5 days/week for 6 weeks. All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). We assessed the impact on functional recovery (Functional Independence Measure - FIM scale), strength (ARM Motricity Index-MI), spasticity (Modified Ashworth Scale-MAS) and pain (Numeric Rating Pain Scale -NRPS).
Detailed Description:
Authors conducted a double blind randomized controlled trial. Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol (N° U0074917/11110) was approved by the Local Ethical Committee of Bergamo, Italy. A number of clinical trials have shown significant advances in upper limb recovery with the use of different sensory - motor techniques, including intensive repetitive movement, constraint-induced movement therapy, functional electrical stimulation treatment, the use of robot-assisted therapy in association with virtual reality. Robot-assisted virtual reality intervention has been shown more effective than conventional interventions and achieved more improvement in upper limb function, however the effect size reported by recent reviews was small and this datum is always reported as a cost-benefit ratio to challenge the use of virtual reality technology in rehabilitation. Robot aided rehabilitation is increasingly used in stroke rehabilitation, with a broad spectrum of applied technology from motor to non-motor aided systems, posing the problem to match the clinical need of the patient with the proper device. In the immediate post stroke period the motor recovery usually do not allow the use of non-motored robot device while the use of motored robot aid after months can be too delayed to obtain some valuable clinical results. The wide range of available devices are certainly a richness in the clinical possibility but also a critical factor in selecting a suitable technology tailored for the clinical feature of the patient at the actual state of the art. This can affect the comparison and interpretation of the literature so far published. Virtual reality therapy recreates favorable conditions to motor learning. Functional recovery is achieved through use-dependent cortical reorganization. The time/intensity of its application is therefore a pivotal point in this learning process. Its duration is not standardized and can varies from 3-4 to 20 hours of total treatment making results accordingly variable, adding further bias in data interpretation. A prerequisite to gain the best results is patients selection and early application when is possible.All these factors, have been ascribed as possible causes of small effect size reported in recent literature in comparing robot-aided virtual reality rehabilitation versus traditional rehabilitation alone.In a group of patients with hemiparesis following stroke, we compared the efficacy of a neurorehabilitation program consist of combination of non-motor robot-assisted therapy with virtual reality (Armeo®Spring) to conventional therapy with the primary aim to verify if the punctual application of what suggested by the single papers is able to improve differences of the efficacy between treatments and, therefore, creating a better effect size. And, as a secondary arm, if it is possible to improve the clinical picture also in post-acute stroke patients and as a secondary aim, if motor selection and intensive treatments can improve the small effect size reported by the literature.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U0074917/11110 | OTHER | Bioethic board | View |