Tele-rehabilitation Through CIMT at Recovering the Function of the Upper Limb and Quality of Life

NCT ID: NCT04877418

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2022-08-30

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.

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.

Conditions

Telerehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TeleCIMT group

One month after baseline evaluations, patients will receive a 3-week program through TeleCIMT.

• Task Oriented Repetitive Training
• Use of the Affected Upper Extremity
• Transfer Package

Group Type: EXPERIMENTAL

TeleCIMT

Intervention Type: PROCEDURE

Mode applied remotely, through the principles and components of the CIMT protocol.

Interventions

TeleCIMT

Mode applied remotely, through the principles and components of the CIMT protocol.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged between 30 and 80 years.
• Who present a single stroke event confirmed by CT,
• Between 5 and 14 points on the NIHSS Scale
• Who have the ability to sit independently.
• Who can follow simple instructions (score greater than 13 on the Mini Menta)l.
• <2 points on the Modified Ashworth Scale on elbow and wrist
• <4 points on the Visual Analog Scale on shoulder.
• That they can perform a functional test of 20 ° of wrist extension and 10 ° of finger extension (take and drop a cloth with the affected hand).

Exclusion Criteria

• Severe cognitive impairment (aphasia, attention deficit, reasoning or memory disorders).
• Severe sensory impairment (visual-auditory).
• Orthopedic limitation (use of a cane).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

ARLETTE PATRICIA DOUSSOULIN SANHUEZA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arlette Doussoulin, PHD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Universidad de La Frontera

Temuco, , Chile

Countries

Chile

Other Identifiers

DIUFRO

Identifier Type: -

Identifier Source: org_study_id