Robotic ExoskeletonNCT06137716
Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19
A study testing Training with a Robotic Hand Exoskeleton in people with Robotic Exoskeleton and Post-acute Covid-19 Syndrome, run by University of Valladolid at 1 site in Spain.
Trial summary
Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Robotic Exoskeleton, Post-acute Covid-19 Syndrome, Rehabilitation Outcome
- What is being tested?
- Training with a Robotic Hand Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 1 Feb 2023
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 30 years old
- Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
- Patients with acute or limited functional or strength impairment in at least one of the upper extremities
- Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
- Patients who give inform written consent.
Who cannot join
- Presence of behavioral disorders
- Dementia (loss of memory of cognitive functions)
- Disorders of consciousness (confusional states and drowsiness)
- Uncontrolled or severely limiting delusions and hallucinations
- Infectious skin diseases
- Rrisk of epileptic seizures due to COVID itself or prior to it
Show all 9Show fewer
- Severe visual impairments
- Severe spasticity with a Modified Ashworth Scale >2, joint stiffness in the wrist and fingers
- Pain with a score >8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Clinical Trials of a Rehabilitation Platform to Accelerate the Recovery of Patients With COVID Neuromotor Sequelae
Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.
- Conditions
- Robotic Exoskeleton, Post-acute Covid-19 Syndrome, Rehabilitation Outcome, Physical And Rehabilitation Medicine
- Being tested
- Training with a Robotic Hand Exoskeleton
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with a Robotic Hand ExoskeletonDevice
The rehabilitation program extended over six consecutive weeks. Each therapy session, lasting 45 minutes, occurred four times per week, resulting in a total of 24 sessions. Within each session, a total of six exercises, consisting of three passive exercises and three bilateral exercises, were performed in an alternating manner. The exercises were executed in the following sequence: 1) Bilateral hand opening and closing; 2) Passive independent finger opening and closing; 3) Bilateral pinch; 4) Passive hand opening and closing; 5) Bilateral hand opening and closing based on a VR-based game involving squeezing an orange; 6) Passive pinch.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group/Arm | Experimental | Participants will rehabilitation with a robotic hand exoskeleton. Receives: Device: Training with a Robotic Hand Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index (BI)
The Barthel Index (BI) modified by Granger et al is an ordinal scale for measuring the ability of an individual to independently execute 15 activities of daily living (ADL) related with mobility and self-care. BI aims to evaluate the degree of independence, with a final score ranging from 0 to 100, where 0 indicates full dependence.
Measured: Baseline / 6 weeks
Functional Independence Measure (MIF)
The Functional Independence Measure (MIF) was designed to provide an indicator of disability independent of a patient's impairment. The scale consists of 18 items to evaluate functional abilities in the area of communication, locomotion, self-care, social cognition, sphincter control and transfers. Each of these items is quantified utilizing a 7-point Likert scale. The total score, obtained by summing the individual item scores, spans from 18 to 126, with 18 denoting a state of complete dependence
Measured: Baseline / 6 weeks
SF-36 Health Questionnaire
The SF-36 Health Questionnaire consists of 36 items designed to assess health-related quality of live. It encompasses eight scales, each comprising 2 to 10 items, which aimed to evaluate various health attributes. These scales include physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health.The score of each scale ranges from 0 to 100, with higher scores indicating a better health-related quality of life.
Measured: Baseline / 6 weeks
Range of motion
The range of motion was analyzed by goniometry measurements using the HandTutor® glove. It provides the active and passive movement of the participants fingers through sensors located in the front and back of the glove.
Measured: Baseline / 6 weeks
Secondary outcomes (1)
Semi-structured interview
Additional information about personal and environmental factors and participatio
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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 Robotic ExoskeletonStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalario Padre Benito Menni
- Responsible party
- Principal investigator, Juan Carlos Fraile, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137716
- Sponsor's protocol ID
- CASVE-NM-22-575
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cisnal A, Alonso-Linaje G, Fraile JC, Perez-Turiel J, Alvarez P, Martinez S. Tackling Post-COVID-19 Rehabilitation Challenges: A Pilot Clinical Trial Investigating the Role of Robotic-Assisted Hand Rehabilitation. J Clin Med. 2024 Mar 7;13(6):1543. doi: 10.3390/jcm13061543.
PubMed 38541769
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Trials of a Rehabilitation Platform to Accelerate the Recovery of Patients With COVID Neuromotor Sequelae
- ClinicalTrials.gov ID
- NCT06137716
- Acronym / sponsor ID
- CASVE-NM-22-575
- Conditions
- Robotic Exoskeleton, Post-acute Covid-19 Syndrome, Rehabilitation Outcome, Physical And Rehabilitation Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Centro Hospitalario Padre Benito Menni
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Nov 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.
Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group/Arm | Experimental | Device: Training with a Robotic Hand ExoskeletonParticipants will rehabilitation with a robotic hand exoskeleton. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 30 years old
- Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
- Patients with acute or limited functional or strength impairment in at least one of the upper extremities
- Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
- Patients who give inform written consent.
Key exclusion criteria (9 listed)
- Presence of behavioral disorders
- Dementia (loss of memory of cognitive functions)
- Disorders of consciousness (confusional states and drowsiness)
- Uncontrolled or severely limiting delusions and hallucinations
- Infectious skin diseases
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 |
|---|---|---|
| Training with a Robotic Hand ExoskeletonThe rehabilitation program extended over six consecutive weeks. Each therapy session, lasting 45 minutes, occurred four times per week, resulting in a total of 24 sessions. Within each session, a total of six exercises, consisting of three passive exercises and three bilateral exercises, were performed in an alternating manner. The exercises were executed in the following sequence: 1) Bilateral hand opening and closing; 2) Passive independent finger opening and closing; 3) Bilateral pinch; 4) Passive hand opening and closing; 5) Bilateral hand opening and closing based on a VR-based game involving squeezing an orange; 6) Passive pinch. | Device | Participant Group/Arm |
Primary outcome
Barthel Index (BI)
Time frame: Baseline / 6 weeks
The Barthel Index (BI) modified by Granger et al is an ordinal scale for measuring the ability of an individual to independently execute 15 activities of daily living (ADL) related with mobility and self-care. BI aims to evaluate the degree of independence, with a final score ranging from 0 to 100, where 0 indicates full dependence.
Functional Independence Measure (MIF)
Time frame: Baseline / 6 weeks
The Functional Independence Measure (MIF) was designed to provide an indicator of disability independent of a patient's impairment. The scale consists of 18 items to evaluate functional abilities in the area of communication, locomotion, self-care, social cognition, sphincter control and transfers. Each of these items is quantified utilizing a 7-point Likert scale. The total score, obtained by summing the individual item scores, spans from 18 to 126, with 18 denoting a state of complete dependence
SF-36 Health Questionnaire
Time frame: Baseline / 6 weeks
The SF-36 Health Questionnaire consists of 36 items designed to assess health-related quality of live. It encompasses eight scales, each comprising 2 to 10 items, which aimed to evaluate various health attributes. These scales include physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health.The score of each scale ranges from 0 to 100, with higher scores indicating a better health-related quality of life.
Range of motion
Time frame: Baseline / 6 weeks
The range of motion was analyzed by goniometry measurements using the HandTutor® glove. It provides the active and passive movement of the participants fingers through sensors located in the front and back of the glove.
1 secondary outcome
Semi-structured interview
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38541769Cisnal A, Alonso-Linaje G, Fraile JC, Perez-Turiel J, Alvarez P, Martinez S. Tackling Post-COVID-19 Rehabilitation Challenges: A Pilot Clinical Trial Investigating the Role of Robotic-Assisted Hand Rehabilitation. J Clin Med. 2024 Mar 7;13(6):1543. doi: 10.3390/jcm13061543.
- Individual participant dataSharing planned: No
Related trials for Robotic Exoskeleton
Recruiting
Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton
Healthy Young Adults
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Active, not recruiting
Dosing of Overground Robotic Gait Training With Functional Outcomes and Neuroplasticity After Spinal Cord Injury
Spinal Cord Injuries
Recruiting
ExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke
Stroke
Not yet recruitingObservational study
Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)
Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with a Robotic Hand Exoskeleton in people with Robotic Exoskeleton and Post-acute Covid-19 Syndrome, run by University of Valladolid at 1 site in Spain.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 Nov 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (BI) (time frame: Baseline / 6 weeks). The study lists 4 primary outcomes in all. 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 NCT06137716, 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 Nov 2023.