StrokeNCT03171012
Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke
A study testing Lower limbs CRT, Upper limbs CRT and Proprioceptive Neuromuscular Facilitation in people with Stroke and Chest Wall Disorder, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen structures. The level of physical activity decreases and cardiorespiratory training(CRT) is indicated to this population to improve the functions of several systems (respiratory, cardiovascular, muscular). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Stroke, Chest Wall Disorder, Quality of Life
- What is being tested?
- Lower limbs CRT, Upper limbs CRT and Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jun 2017to Jun 2026
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have clinical diagnosis of ischemic or hemorrhagic stroke,
- primary for more than six months resulting in hemiparesis;
- Have mental competence assessed through the Mini-Exam of the Mental State-MMSE;
- Be able to walk 10 meters independently, with or without assistive device;
- Absence of other neurological or orthopedic deficiencies unrelated to stroke;
- Without report of associated pulmonary pathology and not be smoker or ex-smoker.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740 - 560
Renata Souza, +55 81 999069957, ftrjps@gmail.com
About this study
Official title: Proprioceptive Neuromuscular Facilitation Repercussions Associated With Cardiorespiratory Training in Postal Individuals Stroke to the Functions Motor, Respiratory and Quality of Life: Randomized Controlled Trial
Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen structures. The level of physical activity decreases and cardiorespiratory training(CRT) is indicated to this population to improve the functions of several systems (respiratory, cardiovascular, muscular). The application of Proprioceptive Neuromuscular Facility(PNF) would imply in the awareness and greater harmony of the functions performed by the trunk of this individual. The objective of this study is to evaluate the effects of respiratory and trunk characteristics of the PNF associated with Cardiorespiratory training in quality of life, gait, distance traveled, peak oxygen consumption, respiratory muscle strength, thoracic cavity volumes, mobility and diaphragmatic thickness of individuals with post stroke.
Read the detailed description
Clinical, randomized, blind and allocation. Forty individuals post-stroke will be randomized into four groups: Experimental Lower Limbs(submitted to LL's CRT associated with PNF); Group control Lower Limbs (submitted LL's CRT associated with respiration). Experimental Upper Limbs (submitted to UP's CRT associated with PNF) and Group control Upper Limbs (submitted to UP's CRT associated with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment. Outcome measures shall be measured by: Stroke Specific Quality of Life Scale; Inertial gear sensor; Maximum volume of oxygen; Spirometry and manovacuometry; Ultrasound of mobility and thickness diaphragmatic; compartmental volumes of the rib cage with opto plethysmography electronics.
For the four groups, the treatment program will have the total duration of one hour including: ten minutes of stretching (five minutes before and five minutes after the therapeutic intervention), ten minutes of rest and 40 minutes of aerobic treatment associated to PNF or to respiration, being performed in 20 Sessions three times a week. The order of application of the techniques will be random, being held until the end of the intervention period. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the American College of Sports Medicine and monitoring constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and side. The breathing exercises will be performed at the same time and in the positions of the PNF. To analyze the data and to achieve the objectives appropriate statistical tests shall be used, according to the normality of and characteristics of the variables.
- Conditions
- Stroke, Chest Wall Disorder, Quality of Life
- Being tested
- Lower limbs CRT, Upper limbs CRT, Proprioceptive Neuromuscular Facilitation, respiration
- Keywords
- Muscle Stretching Exercises
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limbs CRTOther
cycle ergometer for lower limbs
Upper limbs CRTOther
cycle ergometer for upper limbs
Proprioceptive Neuromuscular FacilitationOther
Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.
respirationOther
respiration
| Study group | Role | What they receive |
|---|---|---|
| Lower limbs CRT+ PNF | Experimental | Lower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation Receives: Other: Lower limbs CRT; Other: Proprioceptive Neuromuscular Facilitation |
| Lower limbs CRT + respiration | Active comparator | Lower limbs Cardiorespiratory training associated with respiration Receives: Other: Lower limbs CRT; Other: respiration |
| Upper limbs CRT + PNF | Experimental | Upper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation Receives: Other: Upper limbs CRT; Other: Proprioceptive Neuromuscular Facilitation |
| Upper limbs CRT + respiration | Active comparator | Upper limbs Cardiorespiratory training associated with respiration Receives: Other: Upper limbs CRT; Other: respiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen uptake
maximum oxygen volume consumed during the 6-minute walk test
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Balance
The scale assesses the balance based on 14 common items of day-to-day.
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Quality of life
12 domains: Energy (3 items); Family Relationships (3 items); Language (5 items); Mobility (6 items); Mood (5 items); Personality (3 items); Self-Care (5 items), Superior Member Function (5 items), Social Relations (5 items), Memory / Concentration (3 items), Vision (3 items) and Work / Productivity (3 items).
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Gait
Wireless system consisting of an inertial sensor, consisting of a 3-axis accelerometer, a magnetic sensor and a 3-axis gyroscope, which positioned in L5 allows a functional gait analysis. The system calculates from the data obtained all the temporal and spatial gait parameters required to perform a diagnosis or to define a training strategy. The distance traveled, time of support and balance, step size.
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Compartmental volumes of the rib cage
Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary outcomes (6)
Respiratory function
Spirometry: Will be measured slow vital capacity (Measured in liters), Inspiratory capacity (Measured in liters), forced expiratory volume in the first second (Measured in liters), Forced vital capacity (Measured in liters), forced expiratory volume ratio in the first second by forced vital capacity, peak expiratory flow (Measured in liters per minute).
Measured: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Inspiratory muscle strength
Manovacuometry: Maximal Inspiratory pressure (MIP), Measured in centimeters of water
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Expiratory muscle strength
Manovacuometry: maximal expiratory pressure (MEP), Measured in centimeters of water
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Diaphragmatic thickness
Measurement of the diaphragmatic thickness from the middle of the pleural line to the middle of the peritoneal line.
Measured: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Mobility diaphragmatic
Using convex transducer (3.5MHz) positioned in the right axillary line below the costal margin, the examiner will maintain a firm hand towards the cranial direction. The cranio-caudal excursions of the diaphragm during quiet and forced breathing will record sinusoidal curves, which will represent the diaphragmatic mobility when the trajectory between the baseline at the beginning of the inspiration and the line obtained at the peak of the inspiration is verified.
Measured: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Oxygen Uptake Efficiency Slope
The OUES reflects the relationship between oxygen uptake(˙VO 2 in ml/min) and total ventilation (VE in L/min) and is best described by a single exponential function in almost all subjects.
This index was determined by the following equation: VO2 = a log10VE + b When VO 2 in ml/min is plotted on the y axis and VE in L/min is plotted on the semilog transformed x axis, the slope of this linear relationship, "a", represents the OUES.
Measured: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start19 Jun 2017
- Primary completionDec 2024 (estimated)
- Study completionJun 2026 (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
- Model description
- Forty individuals into four groups: Experimental Lower Limbs (LL's CRT with PNF); Group control Lower Limbs (LL's CRT with respiration). Experimental Upper Limbs (UP's CRT with PNF) and Group control Upper Limbs (UP's CRT with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment. The treatment program will have the full duration of One hour including: ten minutes of stretching (five minutes before and five Minutes after the therapeutic intervention), ten minutes of rest and 40 minutes of Aerobic treatment associated with PNF or to respiration, being performed in 20 Sessions three times a week. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the ACSM and monitoring Constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and Side.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Janaína Pereira de Souza, Universidade Federal do Rio Grande do Norte
- Investigators
- RENATA SOUZA, MASTER, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171012
- Sponsor's protocol ID
- LACAP UFPE/UFRN
- Status last verified
- May 2023
- First submitted
- 23 May 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Souza RJP, Brandao DC, Martins JV, Fernandes J, Dornelas de Andrade A. Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial. Trials. 2020 Feb 14;21(1):184. doi: 10.1186/s13063-019-3923-1.
PubMed 32059691
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Neuromuscular Facilitation Repercussions Associated With Cardiorespiratory Training in Postal Individuals Stroke to the Functions Motor, Respiratory and Quality of Life: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03171012
- Acronym / sponsor ID
- LACAP UFPE/UFRN
- Conditions
- Stroke, Chest Wall Disorder, Quality of Life
- Keywords
- Muscle Stretching Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 May 2017 (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.
Post-stroke hemiparesis causes sequelae in the limbs and also in the trunk and abdomen structures. The level of physical activity decreases and cardiorespiratory training(CRT) is indicated to this population to improve the functions of several systems (respiratory, cardiovascular, muscular). The application of Proprioceptive Neuromuscular Facility(PNF) would imply in the awareness and greater harmony of the functions performed by the trunk of this individual. The objective of this study is to evaluate the effects of respiratory and trunk characteristics of the PNF associated with Cardiorespiratory training in quality of life, gait, distance traveled, peak oxygen consumption, respiratory muscle strength, thoracic cavity volumes, mobility and diaphragmatic thickness of individuals with post stroke.
Detailed description
Clinical, randomized, blind and allocation. Forty individuals post-stroke will be randomized into four groups: Experimental Lower Limbs(submitted to LL's CRT associated with PNF); Group control Lower Limbs (submitted LL's CRT associated with respiration). Experimental Upper Limbs (submitted to UP's CRT associated with PNF) and Group control Upper Limbs (submitted to UP's CRT associated with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment. Outcome measures shall be measured by: Stroke Specific Quality of Life Scale; Inertial gear sensor; Maximum volume of oxygen; Spirometry and manovacuometry; Ultrasound of mobility and thickness diaphragmatic; compartmental volumes of the rib cage with opto plethysmography electronics.
For the four groups, the treatment program will have the total duration of one hour including: ten minutes of stretching (five minutes before and five minutes after the therapeutic intervention), ten minutes of rest and 40 minutes of aerobic treatment associated to PNF or to respiration, being performed in 20 Sessions three times a week. The order of application of the techniques will be random, being held until the end of the intervention period. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the American College of Sports Medicine and monitoring constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and side. The breathing exercises will be performed at the same time and in the positions of the PNF. To analyze the data and to achieve the objectives appropriate statistical tests shall be used, according to the normality of and characteristics of the variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Forty individuals into four groups: Experimental Lower Limbs (LL's CRT with PNF); Group control Lower Limbs (LL's CRT with respiration). Experimental Upper Limbs (UP's CRT with PNF) and Group control Upper Limbs (UP's CRT with respiration). Individuals will be assessed before and immediately after 20 program sessions and one month after the end of treatment. The treatment program will have the full duration of One hour including: ten minutes of stretching (five minutes before and five Minutes after the therapeutic intervention), ten minutes of rest and 40 minutes of Aerobic treatment associated with PNF or to respiration, being performed in 20 Sessions three times a week. For therapy with the CRT used the cycle ergometer for lower or upper limbs, Based on the criteria of the ACSM and monitoring Constant blood pressure, oxygen saturation and perceived exertion. The PNF patterns will be performed in seated, dorsal, ventral and Side.
| Arm | Type | Receives |
|---|---|---|
| Lower limbs CRT+ PNF | Experimental | Other: Lower limbs CRT, Other: Proprioceptive Neuromuscular FacilitationLower Limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation |
| Lower limbs CRT + respiration | Active comparator | Other: Lower limbs CRT, Other: respirationLower limbs Cardiorespiratory training associated with respiration |
| Upper limbs CRT + PNF | Experimental | Other: Upper limbs CRT, Other: Proprioceptive Neuromuscular FacilitationUpper limbs Cardiorespiratory training associated with Proprioceptive Neuromuscular Facilitation |
| Upper limbs CRT + respiration | Active comparator | Other: Upper limbs CRT, Other: respirationUpper limbs Cardiorespiratory training associated with respiration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have clinical diagnosis of ischemic or hemorrhagic stroke,
- primary for more than six months resulting in hemiparesis;
- Have mental competence assessed through the Mini-Exam of the Mental State-MMSE;
- Be able to walk 10 meters independently, with or without assistive device;
- Absence of other neurological or orthopedic deficiencies unrelated to stroke;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Lower limbs CRTcycle ergometer for lower limbs | Other | Lower limbs CRT + respiration, Lower limbs CRT+ PNF |
| Upper limbs CRTcycle ergometer for upper limbs | Other | Upper limbs CRT + PNF, Upper limbs CRT + respiration |
| Proprioceptive Neuromuscular FacilitationProprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side. | Other | Lower limbs CRT+ PNF, Upper limbs CRT + PNF |
| respirationrespiration | Other | Lower limbs CRT + respiration, Upper limbs CRT + respiration |
Primary outcome
Oxygen uptake
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
maximum oxygen volume consumed during the 6-minute walk test
Balance
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
The scale assesses the balance based on 14 common items of day-to-day.
Quality of life
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
12 domains: Energy (3 items); Family Relationships (3 items); Language (5 items); Mobility (6 items); Mood (5 items); Personality (3 items); Self-Care (5 items), Superior Member Function (5 items), Social Relations (5 items), Memory / Concentration (3 items), Vision (3 items) and Work / Productivity (3 items).
Gait
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Wireless system consisting of an inertial sensor, consisting of a 3-axis accelerometer, a magnetic sensor and a 3-axis gyroscope, which positioned in L5 allows a functional gait analysis. The system calculates from the data obtained all the temporal and spatial gait parameters required to perform a diagnosis or to define a training strategy. The distance traveled, time of support and balance, step size.
Compartmental volumes of the rib cage
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph
6 secondary outcomes
Respiratory function
Time frame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Inspiratory muscle strength
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Expiratory muscle strength
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Diaphragmatic thickness
Time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Mobility diaphragmatic
Time frame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Oxygen Uptake Efficiency Slope
Time frame: Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 32059691de Souza RJP, Brandao DC, Martins JV, Fernandes J, Dornelas de Andrade A. Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial. Trials. 2020 Feb 14;21(1):184. doi: 10.1186/s13063-019-3923-1.
- Individual participant dataSharing planned: Undecided
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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.
RENATA SOUZA, MASTER principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limbs CRT, Upper limbs CRT and Proprioceptive Neuromuscular Facilitation in people with Stroke and Chest Wall Disorder, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 6 inclusion and 1 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 11 May 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 Brazil. 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 RENATA SOUZA, MASTER (55 81 999069957, FTRJPS@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen uptake (time frame: Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)). The study lists 5 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 NCT03171012, 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 11 May 2023.