Clinical trial NCT05824416: "Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults With Subacute And Chronic Acquired Brain Injury"
Official title: "Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults (18-80 Years Old) With Hemiparesis Secondary To Acquired Brain Injury In Subacute And Chronic Phases"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Acquired Brain Injury
Adults
Lead sponsor: uMov
Sponsor class: INDUSTRY
Collaborators: name: Clínica los Coihues
First posted: 2023-04-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes on the Fugl-Meyer test
timeFrame: Baseline (t1) and 30 days after (t2)
Secondary outcomes:
measure: ACER-R
timeFrame: Baseline (t1)
measure: MRC
timeFrame: Baseline (t1)
measure: Ashworth
timeFrame: Baseline (t1)
measure: FIM
timeFrame: Baseline (t1) and 30 days after (t2)
measure: Test SF-36
timeFrame: Baseline (t1), 30 days after (t2) and at follow up (90 days)
measure: System Usability Scale
timeFrame: Post intervention (30 days)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clínica Los Coihues
state: Av. Laguna Sur 6561 Estación Central
Study officials:
References: