Clinical trial NCT04877418: Tele-rehabilitation Through CIMT at Recovering the Function of the Upper Limb and Quality of Life
Official title: Tele-rehabilitation Through Constraint Induced Movement Therapy (TeleCIMT) at Recovering the Function of the Upper Limb and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Keywords: Telerehabilitation
Constraint Induced Movement therapy
Upper limb
Outcomes
Functionality
Quality of life
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Upper limb function in patients after stroke.
timeFrame: 3 weeks
Secondary outcomes:
measure: The quality of life of patients after stroke.
timeFrame: 3 weeks.
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Arlette Doussoulin, PHD
role: PRINCIPAL_INVESTIGATOR
References: