"Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults With Subacute And Chronic Acquired Brain Injury"

NCT05824416 | Unknown DMC

• 1 other identifier: SSMOriente030522
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

As part of the rehabilitation techniques, robotic equipment has been introduced for the rehabilitation of the upper extremity with promising results. In this context, the ALBA® devise for the training of the upper extremity is used in this project. This randomized controlled trial will compare a control group (n=16) with an experimental group (n=16) of adults with hemiparesis secondary to an acquired brain lesion. A convenience sample of inpatient will be selected from Los Coihues clinic after concealing the inclusion and exclusion criteria. All participants will perform 45 minutes of training, 5 days a week, for 4 weeks, 20 sessions total. The control group will receive 100% conventional treatment while the experimental group will receive 20 minutes of conventional treatment associated with 25 minutes of ALBA® training. Assessments will be taken before training (t1), at 4 weeks (t2), and at 3 months (t3).

Conditions

Stroke

Keywords

Stroke; Acquired Brain Injury; Adults

Outcome Measures

Primary Outcomes (1)

• Changes on the Fugl-Meyer test

  The Fugl-Meyer Test is a widely used clinical assessment tool for measuring motor recovery in patients with brain damage, especially after a stroke. The test consists of a series of motor activities designed to assess the patient's ability to perform specific movements, such as extending the arm, opening and closing the hand, and standing up from a chair. The movements are scored on a scale of 0 to 2, where 0 means the patient cannot perform the movement and 2 means the patient can perform the movement fully.

  Baseline (t1) and 30 days after (t2)

Secondary Outcomes (6)

• ACER-R

  Baseline (t1)

• MRC

  Baseline (t1)

• Ashworth

  Baseline (t1)

• FIM

  Baseline (t1) and 30 days after (t2)

• Test SF-36

  Baseline (t1), 30 days after (t2) and at follow up (90 days)

Study Arms (2)

ALBA

EXPERIMENTAL

25 minutes of therapy with ALBA and 20 minutes with conventional therapy per session for 5 days a week during 4 weeks.

Device: Experimental: ALBA

Conventional Therapy

ACTIVE COMPARATOR

45 minutes conventional therapy per session for 5 days a week during 4 weeks.

Behavioral: Conventional Therapy

Interventions

Experimental: ALBA DEVICE

Device: Improve Upper Limb Mobility The patients will undergo treatment with the conventional therapy, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise. In addition to training with the ALBA® device, Shoulder flexion, abduction, and external rotation, elbow flexion and extension.

ALBA

Conventional Therapy BEHAVIORAL

The conventionl therapy will receive conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise

Conventional Therapy

Eligibility Criteria

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

You may qualify if:

• Patients of Los Coihues clinic Diagnosis of acquired brain injury. Cognitive capacity and language that allows understanding and following the therapist's instructions.
• Trunk control. Subacute and chronic stage (up to 2 years post injury). Upper extremity paresis able to perform movements with eliminated gravity (modified MRC 2).

You may not qualify if:

• Cardiovascular instability Visual or acoustic limitations. Severe hypertonia (≥3 Ashworth Scale). Upper extremity with passive joint limitation and/or traumatic injury. Neuropsychological alteration (global aphasia, severe attentional deficit, spatial perception alteration).
• Moderate to severe cognitive-behavioral alterations that do not allow the understanding of instructions.
• Severe alterations of consciousness. Deficit in cephalic control. Severe deficit in sedentary balance.

Sponsors & Collaborators

• uMov: lead
• Clínica los Coihues: collaborator

Study Sites (1)

Clínica Los Coihues

Santiago, Av. Laguna Sur 6561 Estación Central, 13106, Chile

RECRUITING

Related Publications (1)

• Salazar-Cifuentes P, Contreras T, Hernandez E, Leiva-Abarca E, Castro-Flores P, San Juan D, Araneda R, Ebner-Karestinos D. Evaluation of ALBA device for upper extremity motor function in adults with subacute and chronic acquired brain injury: a randomised controlled trial protocol in a tertiary clinic of the metropolitan region of Chile. BMJ Open. 2023 Nov 22;13(11):e076774. doi: 10.1136/bmjopen-2023-076774.

  PMID: 37993168 DERIVED

MeSH Terms

Conditions

Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Pamela A Salazar, Ing

CONTACT

+56926444880; pamela@umov.cl

Thomas D Contreras, Ing

CONTACT

+56984836776; thomas@umov.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 21, 2023
• Study Start: June 16, 2023
• Primary Completion: December 29, 2023
• Study Completion: July 11, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available starting 6 months after publication

Locations

CL (1)