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

NCT04877418 | Completed DMC

• 1 other identifier: DIUFRO
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Telerehabilitation

Keywords

Telerehabilitation; Constraint Induced Movement therapy; Upper limb; Outcomes; Functionality; Quality of life

Outcome Measures

Primary Outcomes (1)

• Upper limb function in patients after stroke.

  MAL: It is a structured interview, composed by 30 items, intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting. During the test administration. participants should be told that they can give half scores (i.e., 0.5,1.5,2.5,3.5,4.5) if this is reflective of their ratings. ARAT: It is a performance test that evaluates the ability of the affected upper limb to pick up, move and grasp objects of different size, weight and shape in patients with cortical injury. It is composed of 19 items that examine grip, grip, clamp and gross movement. The total score ranges from 0 (none of the movements were performed) to 57 (all the movements were performed without difficulty). The application of both instruments will be carried out virtually according to standardized procedures.

  3 weeks

Secondary Outcomes (1)

• The quality of life of patients after stroke.

  3 weeks.

Study Arms (1)

TeleCIMT group

EXPERIMENTAL

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

Procedure: TeleCIMT

Interventions

TeleCIMT PROCEDURE

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

TeleCIMT group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, Chile

Location

Study Officials

• Arlette Doussoulin, PHD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: May 5, 2022
• Primary Completion: May 20, 2022
• Study Completion: August 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)