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

"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"

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Experimental: ALBA; Behavioral: Conventional Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela A Salazar, Ing; Phone Number: +56926444880; Email: pamela@umov.cl
• Study Contact Backup: Name: Thomas D Contreras, Ing; Phone Number: +56984836776; Email: thomas@umov.cl

Study Locations

• Chile
  • Av. Laguna Sur 6561 Estación Central
    • Santiago, Av. Laguna Sur 6561 Estación Central, Chile, 13106
      • Recruiting
      • Clínica Los Coihues
      • Contact: Violeta Romero, Licenciate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALBA; 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; 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.
Active Comparator: Conventional Therapy; 45 minutes conventional therapy per session for 5 days a week during 4 weeks.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACER-R	The ACER-R test can be used in the evaluation of individuals who have suffered cognitive damage, such as a stroke or traumatic brain injury. In this case, the test is used to measure cognitive function and determine the degree of cognitive impairment that has occurred. In terms of measurement units, the ACER-R uses a standardized scoring system based on the individual's age and the average population score. Scores are expressed in terms of raw scores, standard scores, and percentiles. These scores are used to compare the individual's cognitive capacity with that of the general population and to evaluate the degree of cognitive impairment that has occurred. The minimum possible score is 0 and the maximum is 143.	Baseline (t1)
MRC	The MRC (Medical Research Council) test is an assessment tool used to measure muscle strength in different muscle groups of the body. It involves the evaluator applying an opposing force to the muscle being evaluated while the individual performs a maximum contraction for several seconds. The strength is measured on a scale of 0 to 5, where 0 indicates a complete absence of muscle contraction and 5 indicates a complete normal contraction.	Baseline (t1)
Ashworth	The Ashworth test is an assessment tool used to measure muscle tone in people with neurological diseases such as spasticity. It involves evaluating the resistance offered by a muscle to passive movement, i.e. when the evaluator moves the patient's limb in a specific direction without the patient actively participating. During the test, the evaluator moves the patient's limb and evaluates the degree of resistance or muscle rigidity on a scale of 0 to 4, where 0 indicates the absence of resistance and 4 indicates severe muscle rigidity. The Ashworth test is used to assess the degree of spasticity in people with brain injuries, cerebral palsy, and other neurological diseases, and can be useful in guiding treatment and rehabilitation.	Baseline (t1)
FIM	The FIM (Functional Independence Measure) test is an evaluation tool used to measure functional independence in basic activities of daily living in individuals with physical, neurological, or cognitive disabilities. The test consists of an evaluation of 18 items covering six areas of skills: self-care, sphincter control, transfers, locomotion, communication, and cognition. Each item is scored from 1 to 7, where 1 indicates total dependence and 7 indicates total independence. The total score is used to determine the individual's level of functional dependence and evaluate the effectiveness of interventions and rehabilitation programs.	Baseline (t1) and 30 days after (t2)
Test SF-36	The SF-36 (Short Form-36) is a health survey questionnaire that measures the individual's overall health and quality of life. It consists of 36 questions that assess eight different health domains, including physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The test is widely used in clinical and research settings to evaluate the impact of health interventions and to compare health outcomes between different populations. The SF-36 questionnaire uses a scoring system that ranges from 0 to 100 for each of the eight health domains. A score of 100 indicates the highest level of health or quality of life, while a score of 0 indicates the lowest. Therefore, the total possible score is 800 (100 x 8 domains).	Baseline (t1), 30 days after (t2) and at follow up (90 days)
System Usability Scale	The System Usability Scale (SUS) is a questionnaire used to evaluate the usability and user-friendliness of a wide range of technological products, including software, websites, and hardware. The SUS consists of ten questions that assess the user's perception of various aspects of the product's usability, such as its ease of use, efficiency, and learnability. Each question is answered on a five-point scale, ranging from "strongly disagree" to "strongly agree." The SUS score ranges from 0 to 100, with a higher score indicating greater usability and user satisfaction.	Post intervention (30 days)

Collaborators and Investigators

• Sponsor: uMov
• Collaborators: Clínica los Coihues

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Estimated): December 29, 2023
• Study Completion (Estimated): July 11, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Adults; Acquired Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: SSMOriente030522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared only in a research framework (e.g., for publication) and on condition of clear acknowledgment of the source by citing the authors. Thus, data will be available upon reasonable request by contacting the corresponding author. The "recipient" must sign a data sharing agreement (DSA) specifying possible (re)uses and the purpose of it.
• IPD Sharing Time Frame: Data will become available starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No