StrokeNCT05824416
"Evaluation Of ALBA® Device for Upper Extremity Motor Function In Adults With Subacute And Chronic Acquired Brain Injury"
A study testing Experimental: ALBA and Conventional Therapy in people with Stroke, run by uMov at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental: ALBA and Conventional Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 16 Jun 2023to 11 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clínica Los Coihues
Santiago, Av. Laguna Sur 6561 Estación Central, 13106
Violeta Romero, Licenciate
About this study
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"
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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Experimental: ALBA, Conventional Therapy
- Keywords
- Stroke, Acquired Brain Injury, Adults
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: ALBADevice
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 TherapyBehavioural
The conventionl therapy will receive conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise
| Study group | Role | What they receive |
|---|---|---|
| ALBA | Experimental | 25 minutes of therapy with ALBA and 20 minutes with conventional therapy per session for 5 days a week during 4 weeks. Receives: Device: Experimental: ALBA |
| Conventional Therapy | Active comparator | 45 minutes conventional therapy per session for 5 days a week during 4 weeks. Receives: Behavioral: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (t1) and 30 days after (t2)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Post intervention (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start16 Jun 2023
- Primary completion29 Dec 2023 (estimated)
- Study completion11 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- uMov
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clínica los Coihues
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824416
- Sponsor's protocol ID
- SSMOriente030522
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37993168
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT05824416
- Acronym / sponsor ID
- SSMOriente030522
- Conditions
- Stroke
- Keywords
- Stroke, Acquired Brain Injury, Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- uMovIndustry (pharma, biotech, devices)
- Collaborators
- Clínica los Coihues
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 11 Jul 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALBA | Experimental | Device: Experimental: ALBA25 minutes of therapy with ALBA and 20 minutes with conventional therapy per session for 5 days a week during 4 weeks. |
| Conventional Therapy | Active comparator | Behavioral: Conventional Therapy45 minutes conventional therapy per session for 5 days a week during 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: ALBADevice: 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. | Device | ALBA |
| Conventional TherapyThe conventionl therapy will receive conventional treatment, consisting of four types of exercises, including supine and seated exercises, bimanual seated activity, and bipedal exercise | Behavioural | Conventional Therapy |
Primary outcome
Changes on the Fugl-Meyer test
Time frame: Baseline (t1) and 30 days after (t2)
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.
6 secondary outcomes
ACER-R
Time frame: Baseline (t1)
MRC
Time frame: Baseline (t1)
Ashworth
Time frame: Baseline (t1)
FIM
Time frame: Baseline (t1) and 30 days after (t2)
Test SF-36
Time frame: Baseline (t1), 30 days after (t2) and at follow up (90 days)
System Usability Scale
Time frame: Post intervention (30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 37993168Salazar-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: ALBA and Conventional Therapy in people with Stroke, run by uMov at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela A Salazar, Ing (+56926444880, pamela@umov.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the Fugl-Meyer test (time frame: Baseline (t1) and 30 days after (t2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05824416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.