TelerehabilitationTeleCIMTNCT04877418
Tele-rehabilitation Through CIMT at Recovering the Function of the Upper Limb and Quality of Life
A study testing TeleCIMT in people with Telerehabilitation, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
The current pandemic scenario is immensely challenging for healthcare professionals. Telerehabilitation,is a promising option that benefited many people, allowing continuity of therapeutic processes and promoting the admission of people without prior access to rehabilitation programs. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- TeleCIMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChile
- Study dates
- 5 May 2022to 30 Aug 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 30 and 80 years.
- Who present a single stroke event confirmed by CT,
- Between 5 and 14 points on the NIHSS Scale
- Who have the ability to sit independently.
- Who can follow simple instructions (score greater than 13 on the Mini Menta)l.
- <2 points on the Modified Ashworth Scale on elbow and wrist
- <4 points on the Visual Analog Scale on shoulder.
- That they can perform a functional test of 20 ° of wrist extension and 10 ° of finger extension (take and drop a cloth with the affected hand).
Who cannot join
- Severe cognitive impairment (aphasia, attention deficit, reasoning or memory disorders).
- Severe sensory impairment (visual-auditory).
- Orthopedic limitation (use of a cane).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-rehabilitation Through Constraint Induced Movement Therapy (TeleCIMT) at Recovering the Function of the Upper Limb and Quality of Life
The current pandemic scenario is immensely challenging for healthcare professionals. Telerehabilitation,is a promising option that benefited many people, allowing continuity of therapeutic processes and promoting the admission of people without prior access to rehabilitation programs. This modality has shown comparable results with conventional rehabilitation strategies, applied in patients with neurological pathologies. However, the modalities applied and the quality of the studies are insufficient to establish their real benefits and effectiveness.
Strategies such as CIMT, have been shown to be effective in improving upper limb function and restoring quality of life in stroke survivors. However, there is little evidence on its effectiveness when administered under telerehabilitation modality.
Read the detailed description
Objective To determine if movement-induced restriction therapy, delivered through telerehabilitation (TeleCIMT), recovers function and improves quality of life in patients with brachial sequelae, after a stroke.
Methodology A prospective, single-group experimental study will be conducted. The sample will be of an intentional type, selected according to meeting the inclusion criteria. Each participant will be evaluated three times, at the beginning, middle and end of the intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30 (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The difference between these measurements in each patient (change score) will express the progress (or setback) obtained through this modality of intervention via telerehabilitation. Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the recovery measures as dependent variables. In all analyzes, results with p values less than or equal to 0.05 will be considered statistically significant.
Expected results Through this proposal, the aim is to promote a line of research that allows the development of scientific evidence in the area of telerehabilitation in subjects with neurological pathologies. This information will benefit numerous professionals, promoting timely access to rehabilitation, providing continuity in therapeutic processes and reversing levels of disability due to neurological pathologies.
- Conditions
- Telerehabilitation
- Being tested
- TeleCIMT
- Keywords
- Telerehabilitation, Constraint Induced Movement therapy, Upper limb, Outcomes, Functionality, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleCIMTProcedure or surgery
Mode applied remotely, through the principles and components of the CIMT protocol.
| Study group | Role | What they receive |
|---|---|---|
| TeleCIMT group | Experimental | One month after baseline evaluations, patients will receive a 3-week program through TeleCIMT.
* Task Oriented Repetitive Training
* Use of the Affected Upper Extremity
* Transfer Package Receives: Procedure: TeleCIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb function in patients after stroke.
MAL: It is a structured interview, composed by 30 items, intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting. During the test administration. participants should be told that they can give half scores (i.e., 0.5,1.5,2.5,3.5,4.5) if this is reflective of their ratings.
ARAT: It is a performance test that evaluates the ability of the affected upper limb to pick up, move and grasp objects of different size, weight and shape in patients with cortical injury. It is composed of 19 items that examine grip, grip, clamp and gross movement. The total score ranges from 0 (none of the movements were performed) to 57 (all the movements were performed without difficulty).
The application of both instruments will be carried out virtually according to standardized procedures.
Measured: 3 weeks
Secondary outcomes (1)
The quality of life of patients after stroke.
It will be evaluated through the ECVI-38 scale, which comprises 38 items grouped into 8 subscales: physical state, communication, cognition, emotions, feelings, basic activities of daily life, common activities of daily life and socio-family functioning. It also contains two additional questions about sexual relationships and work activity. The application will be carried out virtually according to standardized procedures in the manual.
The formulation of responses is with a Likert scale, from 5 to 1, where 5 is the worst score as evaluated and 1 is where the patient reports having no difficulty.
Measured: 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start5 May 2022
- Primary completion20 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARLETTE PATRICIA DOUSSOULIN SANHUEZA, Universidad de La Frontera
- Investigators
- Arlette Doussoulin, PHD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877418
- Sponsor's protocol ID
- DIUFRO
- Acronym
- TeleCIMT
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research team is in talks with their counterpart from the University of Sydney, led by Dr. Lauren Christie, who are developing research on the same topic of study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation Through Constraint Induced Movement Therapy (TeleCIMT) at Recovering the Function of the Upper Limb and Quality of Life
- ClinicalTrials.gov ID
- NCT04877418
- Acronym / sponsor ID
- TeleCIMT / DIUFRO
- Conditions
- Telerehabilitation
- Keywords
- Telerehabilitation, Constraint Induced Movement therapy, Upper limb, Outcomes, Functionality, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 7 May 2021 (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.
The current pandemic scenario is immensely challenging for healthcare professionals. Telerehabilitation,is a promising option that benefited many people, allowing continuity of therapeutic processes and promoting the admission of people without prior access to rehabilitation programs. This modality has shown comparable results with conventional rehabilitation strategies, applied in patients with neurological pathologies. However, the modalities applied and the quality of the studies are insufficient to establish their real benefits and effectiveness.
Strategies such as CIMT, have been shown to be effective in improving upper limb function and restoring quality of life in stroke survivors. However, there is little evidence on its effectiveness when administered under telerehabilitation modality.
Detailed description
Objective To determine if movement-induced restriction therapy, delivered through telerehabilitation (TeleCIMT), recovers function and improves quality of life in patients with brachial sequelae, after a stroke.
Methodology A prospective, single-group experimental study will be conducted. The sample will be of an intentional type, selected according to meeting the inclusion criteria. Each participant will be evaluated three times, at the beginning, middle and end of the intervention using TeleCIMT. The evaluation scales to be used will be Motor Activity Log-30 (MAL-30) and Action Research Arm for function and ECVI-38 scale for quality of life. The difference between these measurements in each patient (change score) will express the progress (or setback) obtained through this modality of intervention via telerehabilitation. Specifically, the effects of the TeleCIMT will be examined by one-factor within-subject analysis of variance (ANOVA) using time (T1, T2, and T3) as the independent variable and the recovery measures as dependent variables. In all analyzes, results with p values less than or equal to 0.05 will be considered statistically significant.
Expected results Through this proposal, the aim is to promote a line of research that allows the development of scientific evidence in the area of telerehabilitation in subjects with neurological pathologies. This information will benefit numerous professionals, promoting timely access to rehabilitation, providing continuity in therapeutic processes and reversing levels of disability due to neurological pathologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TeleCIMT group | Experimental | Procedure: TeleCIMTOne month after baseline evaluations, patients will receive a 3-week program through TeleCIMT. * Task Oriented Repetitive Training * Use of the Affected Upper Extremity * Transfer Package |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged between 30 and 80 years.
- Who present a single stroke event confirmed by CT,
- Between 5 and 14 points on the NIHSS Scale
- Who have the ability to sit independently.
- Who can follow simple instructions (score greater than 13 on the Mini Menta)l.
Key exclusion criteria (3 listed)
- Severe cognitive impairment (aphasia, attention deficit, reasoning or memory disorders).
- Severe sensory impairment (visual-auditory).
- Orthopedic limitation (use of a cane).
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 |
|---|---|---|
| TeleCIMTMode applied remotely, through the principles and components of the CIMT protocol. | Procedure or surgery | TeleCIMT group |
Primary outcome
Upper limb function in patients after stroke.
Time frame: 3 weeks
MAL: It is a structured interview, composed by 30 items, intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting. During the test administration. participants should be told that they can give half scores (i.e., 0.5,1.5,2.5,3.5,4.5) if this is reflective of their ratings. ARAT: It is a performance test that evaluates the ability of the affected upper limb to pick up, move and grasp objects of different size, weight and shape in patients with cortical injury. It is composed of 19 items that examine grip, grip, clamp and gross movement. The total score ranges from 0 (none of the movements were performed) to 57 (all the movements were performed without difficulty). The application of both instruments will be carried out virtually according to standardized procedures.
1 secondary outcome
The quality of life of patients after stroke.
Time frame: 3 weeks.
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 9 Nov 2022.
- Individual participant dataSharing planned: No. The research team is in talks with their counterpart from the University of Sydney, led by Dr. Lauren Christie, who are developing research on the same topic of study.
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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.
Arlette Doussoulin, PHD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleCIMT in people with Telerehabilitation, run by Universidad de La Frontera 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 8 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: finished, as of the sponsor's last update on 9 Nov 2022. 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?
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?
Upper limb function in patients after stroke. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2022.