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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Experimental: ALBA
Conventional Therapy
Sponsored by
uMov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Acquired Brain Injury, Adults

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clínica Los CoihuesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALBA

Conventional Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.

Full Information

First Posted
April 5, 2023
Last Updated
September 14, 2023
Sponsor
uMov
Collaborators
Clínica los Coihues
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1. Study Identification

Unique Protocol Identification Number
NCT05824416
Brief Title
"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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
July 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
uMov
Collaborators
Clínica los Coihues

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Acquired Brain Injury, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALBA
Arm Type
Experimental
Arm Description
25 minutes of therapy with ALBA and 20 minutes with conventional therapy per session for 5 days a week during 4 weeks.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
45 minutes conventional therapy per session for 5 days a week during 4 weeks.
Intervention Type
Device
Intervention Name(s)
Experimental: ALBA
Intervention Description
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
Behavioral
Intervention Name(s)
Conventional Therapy
Intervention Description
The conventionl therapy will receive conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise
Primary Outcome Measure Information:
Title
Changes on the Fugl-Meyer test
Description
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.
Time Frame
Baseline (t1) and 30 days after (t2)
Secondary Outcome Measure Information:
Title
ACER-R
Description
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.
Time Frame
Baseline (t1)
Title
MRC
Description
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.
Time Frame
Baseline (t1)
Title
Ashworth
Description
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.
Time Frame
Baseline (t1)
Title
FIM
Description
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.
Time Frame
Baseline (t1) and 30 days after (t2)
Title
Test SF-36
Description
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).
Time Frame
Baseline (t1), 30 days after (t2) and at follow up (90 days)
Title
System Usability Scale
Description
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.
Time Frame
Post intervention (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela A Salazar, Ing
Phone
+56926444880
Email
pamela@umov.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas D Contreras, Ing
Phone
+56984836776
Email
thomas@umov.cl
Facility Information:
Facility Name
Clínica Los Coihues
City
Santiago
State/Province
Av. Laguna Sur 6561 Estación Central
ZIP/Postal Code
13106
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Romero, Licenciate

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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