StrokeNCT06127485
Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke
A study testing Neuropilates+occupational therapy and physiotherapy conventional and Occupational Therapy and Physiotherapy conventional in people with Stroke and Occupational Therapy, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Occupational Therapy, Physiotherapy
- What is being tested?
- Neuropilates+occupational therapy and physiotherapy conventional and Occupational Therapy and Physiotherapy conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 15 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- present a diagnosis of ischemic or hemorrhagic stroke with a minimum evolution of 3 months;
- be over 18 years of age;
- regularly attend rehabilitation treatment at the Physiocare Madrid center;
- present moderate functional problems (score greater than 65 on the Barthel Index);
- not present moderate cognitive impairment (Mini Mental State Examination less than 18 points);
- not present nasogastric tubes;
- accept to participate voluntarily in the study and sign the informed consent form;
- be able to participate in the study and sign the informed consent form.
Who cannot join
- time of evolution of less than 3 months;
- other conditions of the central nervous system (tumors, anoxia, cranioencephalic trauma, etc.);
- cardiorespiratory or neurodegenerative disorders, severe brain damage or a score of 6 or higher on the Reisberg Deterioration Scale (GDS);
- a severely impaired level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
- receiving other complementary rehabilitative therapy;
- a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
- a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
- a severe deterioration in the level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke: A Randomized Clinical Trial
Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. However, there are no studies on the efficacy of the method in the recovery of the upper limb and the improvement of autonomy after stroke.
Methods: Randomized double-blind clinical trial with patients with stroke in semi-acute period, randomized into experimental group (EG) (conventional rehabilitation and Pilates) or control group (CG) (conventional rehabilitation).
Read more
After randomization and initial evaluation, the intervention will begin (2 sessions per week, 3 months). After completion, there will be post-intervention assessment, and another one at 1 month.
Intervention: The CG will receive 30 minutes of physical therapy and 30 minutes of occupational therapy. The SG will receive 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates.
Assessment instruments: Mean Functional Independence; Functional Range Test; Timed 'Up and Go'; Nine Hole Peg Test; Box and Block Test; Arm, Shoulder and Hand Disabilities Questionnaire; Client Satisfaction Questionnaire.
- Conditions
- Stroke, Occupational Therapy, Physiotherapy
- Being tested
- Neuropilates+occupational therapy and physiotherapy conventional, Occupational Therapy and Physiotherapy conventional
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropilates+occupational therapy and physiotherapy conventionalProcedure or surgery
Participants assigned to the experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physical therapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. Pilates routines will be performed on a mat through the practice of Pilates activation exercises. Each participant will be given the necessary adaptations of each exercise according to their difficulties/disabilities.
Occupational Therapy and Physiotherapy conventionalProcedure or surgery
Conventional physical therapy in both groups will include stretching techniques and muscle activation of the lower limb and gait reeducation. Conventional occupational therapy will include stretching techniques and muscle activation in the upper limb as well as training in activities of daily living and functional activities of the upper limb.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The treatment received is a combination of physiotherapy and conventional occupational therapy sessions two days a week, with a duration of 60 minutes divided into 30 minutes of physiotherapy and 30 minutes of occupational therapy. Receives: Procedure: Occupational Therapy and Physiotherapy conventional |
| Experimental Group | Experimental | The experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. Receives: Procedure: Neuropilates+occupational therapy and physiotherapy conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independance Measure (FIM)
an instrument that measures the level of functional independence in activities of daily living. It provides information mainly on motor and cognitive performance by means of 18 items.
items. The score ranges from 1 to 7, with a higher score corresponding to a higher level of functional independence. Administration was carried out by means of task observation and interview.
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Functional Reach Test
A test that measures the maximum distance an individual can move their center of gravity to the limits of their base of support. In a relaxed standing position, with feet at hip level, the person is instructed to make a shoulder flexion to 90 degrees and keep the hand extended. The person has to go forward as far as he/she can. The examiner records the final measurement that they manage to shift their center of gravity. Two practice trials and three recorded trials are completed, and the average is the overall mean score. This test is recorded in centimeters.
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Timed 'Up and Go' (TUG)
A test that measures the time it takes a person to get up from a chair, walk a distance of 3 meters, turn, return to the chair and sit down. This test is responsible for exploring balance and walking speed. This test is recorded in seconds
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Nine Hole Peg Test
This test measures fine manual dexterity. This is considered a "gold standard" to evaluate fine manual dexterity. It consists of placing a number of pins on a board with 9 holes and removing them as quickly as possible. This test records the time that the person uses with each upper limb.
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Box and Block Test
Test that measures the gross motor skills of the upper limbs. It consists of a wooden box that is divided into two halves by an axis, and consists of passing from one half to the other as many wooden blocks as possible with each upper limb, for 1 minute. In this test, the number of blocks that the person is able to pass in one minute with each upper limb is recorded.
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
This test measures symptoms and some aspects of activity and participation according to the 9 domains described in the International Classification of Functioning, Disability and Health in the upper extremity. It is an easy and quick test to administer
Measured: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Secondary outcomes (1)
Client Satisfaction Questionnaire (CSQ-8)
This is a self-administered questionnaire, consisting of 8 questions that evaluate the level of satisfaction in relation to the care and quality of service received, as well as the degree of fulfillment of the patient's expectations prior to the intervention. The answers are coded from 1-4, the total score of the questionnaire being 32 points, with higher values indicating greater satisfaction with the treatment received. In its adaptation to Spanish, it presents adequate psychometric properties and maintains the properties of the initial questionnaire. It is therefore suitable for evaluating satisfaction with the health service received in the Spanish population.
Measured: post-intervention (immediately after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jul 2023
- Primary completion24 Jul 2023
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Garcia Bravo, Universidad Rey Juan Carlos
- Investigators
- Sara García-Bravo, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127485
- Sponsor's protocol ID
- 3006202326123
- Status last verified
- Nov 2023
- First submitted
- 28 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuropilates on Rehabilitation Programs for Chronic Stroke: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06127485
- Acronym / sponsor ID
- 3006202326123
- Conditions
- Stroke, Occupational Therapy, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 13 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.
Introduction: Cerebrovascular damage (stroke) can generate motor or cognitive sequelae, making rehabilitation (such as the Pilates method) necessary to improve autonomy and quality of life. However, there are no studies on the efficacy of the method in the recovery of the upper limb and the improvement of autonomy after stroke.
Methods: Randomized double-blind clinical trial with patients with stroke in semi-acute period, randomized into experimental group (EG) (conventional rehabilitation and Pilates) or control group (CG) (conventional rehabilitation).
After randomization and initial evaluation, the intervention will begin (2 sessions per week, 3 months). After completion, there will be post-intervention assessment, and another one at 1 month.
Intervention: The CG will receive 30 minutes of physical therapy and 30 minutes of occupational therapy. The SG will receive 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates.
Assessment instruments: Mean Functional Independence; Functional Range Test; Timed 'Up and Go'; Nine Hole Peg Test; Box and Block Test; Arm, Shoulder and Hand Disabilities Questionnaire; Client Satisfaction Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Occupational Therapy and Physiotherapy conventionalThe treatment received is a combination of physiotherapy and conventional occupational therapy sessions two days a week, with a duration of 60 minutes divided into 30 minutes of physiotherapy and 30 minutes of occupational therapy. |
| Experimental Group | Experimental | Procedure: Neuropilates+occupational therapy and physiotherapy conventionalThe experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physiotherapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- present a diagnosis of ischemic or hemorrhagic stroke with a minimum evolution of 3 months;
- be over 18 years of age;
- regularly attend rehabilitation treatment at the Physiocare Madrid center;
- present moderate functional problems (score greater than 65 on the Barthel Index);
- not present moderate cognitive impairment (Mini Mental State Examination less than 18 points);
Key exclusion criteria (8 listed)
- time of evolution of less than 3 months;
- other conditions of the central nervous system (tumors, anoxia, cranioencephalic trauma, etc.);
- cardiorespiratory or neurodegenerative disorders, severe brain damage or a score of 6 or higher on the Reisberg Deterioration Scale (GDS);
- a severely impaired level of consciousness or a score of 8 or lower on the Glasgow Coma Scale (GCS);
- receiving other complementary rehabilitative therapy;
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 |
|---|---|---|
| Neuropilates+occupational therapy and physiotherapy conventionalParticipants assigned to the experimental group received 60 minutes of conventional rehabilitation combined with the Pilates Method, divided into 20 minutes of physical therapy, 20 minutes of occupational therapy and 20 minutes of Pilates Method. Pilates routines will be performed on a mat through the practice of Pilates activation exercises. Each participant will be given the necessary adaptations of each exercise according to their difficulties/disabilities. | Procedure or surgery | Experimental Group |
| Occupational Therapy and Physiotherapy conventionalConventional physical therapy in both groups will include stretching techniques and muscle activation of the lower limb and gait reeducation. Conventional occupational therapy will include stretching techniques and muscle activation in the upper limb as well as training in activities of daily living and functional activities of the upper limb. | Procedure or surgery | Control group |
Primary outcome
Functional Independance Measure (FIM)
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
an instrument that measures the level of functional independence in activities of daily living. It provides information mainly on motor and cognitive performance by means of 18 items. items. The score ranges from 1 to 7, with a higher score corresponding to a higher level of functional independence. Administration was carried out by means of task observation and interview.
Functional Reach Test
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
A test that measures the maximum distance an individual can move their center of gravity to the limits of their base of support. In a relaxed standing position, with feet at hip level, the person is instructed to make a shoulder flexion to 90 degrees and keep the hand extended. The person has to go forward as far as he/she can. The examiner records the final measurement that they manage to shift their center of gravity. Two practice trials and three recorded trials are completed, and the average is the overall mean score. This test is recorded in centimeters.
Timed 'Up and Go' (TUG)
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
A test that measures the time it takes a person to get up from a chair, walk a distance of 3 meters, turn, return to the chair and sit down. This test is responsible for exploring balance and walking speed. This test is recorded in seconds
Nine Hole Peg Test
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
This test measures fine manual dexterity. This is considered a "gold standard" to evaluate fine manual dexterity. It consists of placing a number of pins on a board with 9 holes and removing them as quickly as possible. This test records the time that the person uses with each upper limb.
Box and Block Test
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
Test that measures the gross motor skills of the upper limbs. It consists of a wooden box that is divided into two halves by an axis, and consists of passing from one half to the other as many wooden blocks as possible with each upper limb, for 1 minute. In this test, the number of blocks that the person is able to pass in one minute with each upper limb is recorded.
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)
This test measures symptoms and some aspects of activity and participation according to the 9 domains described in the International Classification of Functioning, Disability and Health in the upper extremity. It is an easy and quick test to administer
1 secondary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: post-intervention (immediately after the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Sara García-Bravo study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropilates+occupational therapy and physiotherapy conventional and Occupational Therapy and Physiotherapy conventional in people with Stroke and Occupational Therapy, run by Universidad Rey Juan Carlos 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 8 inclusion and 8 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 13 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?
Results are not available in the source record.
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?
Functional Independance Measure (FIM) (time frame: pre-intervention (baseline); post-intervention (immediately after the intervention) and follow up (one month after the intervention)). The study lists 6 primary outcomes in all. 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 13 Nov 2023.