Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04877418
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2021-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tele-rehabilitation Through CIMT at Recovering the Function of the Upper Limb and Quality of Life
Sponsor:
Universidad de La Frontera
Organization:
Study Overview
Official Title:
Tele-rehabilitation Through Constraint Induced Movement Therapy (TeleCIMT) at Recovering the Function of the Upper Limb and Quality of Life
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
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:
TeleCIMT
Brief Summary:
The current pandemic scenario is immensely challenging for healthcare professionals. Telerehabilitation,is a promising option that benefited many people, allowing continuity of therapeutic processes and promoting the admission of people without prior access to rehabilitation programs. This modality has shown comparable results with conventional rehabilitation strategies, applied in patients with neurological pathologies. However, the modalities applied and the quality of the studies are insufficient to establish their real benefits and effectiveness.
Strategies such as CIMT, have been shown to be effective in improving upper limb function and restoring quality of life in stroke survivors. However, there is little evidence on its effectiveness when administered under telerehabilitation modality.
Strategies such as CIMT, have been shown to be effective in improving upper limb function and restoring quality of life in stroke survivors. However, there is little evidence on its effectiveness when administered under telerehabilitation modality.
Detailed Description:
Objective To determine if movement-induced restriction therapy, delivered through telerehabilitation (TeleCIMT), recovers function and improves quality of life in patients with brachial sequelae, after a stroke.
Methodology A prospective, single-group experimental study will be conducted. The sample will be of an intentional type, selected according to meeting the inclusion criteria. Each participant will be evaluated three times, at the beginning, middle and end of the intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30 (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The difference between these measurements in each patient (change score) will express the progress (or setback) obtained through this modality of intervention via telerehabilitation. Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the recovery measures as dependent variables. In all analyzes, results with p values less than or equal to 0.05 will be considered statistically significant.
Expected results Through this proposal, the aim is to promote a line of research that allows the development of scientific evidence in the area of telerehabilitation in subjects with neurological pathologies. This information will benefit numerous professionals, promoting timely access to rehabilitation, providing continuity in therapeutic processes and reversing levels of disability due to neurological pathologies.
Methodology A prospective, single-group experimental study will be conducted. The sample will be of an intentional type, selected according to meeting the inclusion criteria. Each participant will be evaluated three times, at the beginning, middle and end of the intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30 (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The difference between these measurements in each patient (change score) will express the progress (or setback) obtained through this modality of intervention via telerehabilitation. Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the recovery measures as dependent variables. In all analyzes, results with p values less than or equal to 0.05 will be considered statistically significant.
Expected results Through this proposal, the aim is to promote a line of research that allows the development of scientific evidence in the area of telerehabilitation in subjects with neurological pathologies. This information will benefit numerous professionals, promoting timely access to rehabilitation, providing continuity in therapeutic processes and reversing levels of disability due to neurological pathologies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: