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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2024-07-11

Brief Summary

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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).

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Detailed Description

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This study aims to investigate the efficacy of occupational therapy for patients with upper limb disabilities, specifically utilizing the ALBA® device for training. Robotic equipment has been introduced as part of rehabilitation techniques for the upper extremity with promising results, and the ALBA® device is being used in this project to assess its effectiveness. A randomized controlled trial will be conducted, comparing a control group receiving conventional treatment and an experimental group receiving a combination of conventional treatment and ALBA® training. Participants will be adults with hemiparesis secondary to an acquired brain lesion, selected from a convenience sample of inpatients at 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, totaling 20 sessions. The control group will receive 45 minutes of conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise. The experimental group will receive 20 minutes of conventional treatment associated with 25 minutes of supervised ALBA® training. The ALBA® training will involve customizing the device software to the patient's progress and adjusting the angles of inclination for exercises. Each session will feature a virtual assistant guiding patients through a sequence of exercises, including a brief practice period, two series of repetitions of different movements, and a free exercise. Rest periods of 2-3 minutes will be given between each series. Assessments will be taken before training (t1), at 4 weeks (t2), and at 3 months (t3) to evaluate the effectiveness of the two treatment methods. This study design allows for the evaluation of both short and long-term effects. Overall, this study aims to provide evidence for the effectiveness of the ALBA® device for the rehabilitation of upper extremities and contribute to the existing literature on the use of robotic equipment in occupational therapy.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ALBA

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

Group Type EXPERIMENTAL

Experimental: ALBA

Intervention Type 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.

Conventional Therapy

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

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type 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

Interventions

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Experimental: ALBA

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.

Intervention Type DEVICE

Conventional Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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).

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No