Addition of Proprioceptive Neuromuscular Facilitation to Cardio Respiratory Training Post Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03171012
• Other study ID #: LACAP UFPE/UFRN
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: Universidade Federal do Rio Grande do Norte
• Contact: RENATA SOUZA, MASTER
• Phone: 55 81 999069957
• Email: FTRJPS[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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. Exclusion Criteria: -

Related Conditions & MeSH terms

• Chest Wall Disorder
• Quality of Life
• Stroke

Intervention

Other:
• Lower limbs CRT
cycle ergometer for lower limbs
• Upper limbs CRT
cycle ergometer for upper limbs
• Proprioceptive Neuromuscular Facilitation
Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.
• respiration
respiration

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen uptake	maximum oxygen volume consumed during the 6-minute walk test	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Primary	Balance	The scale assesses the balance based on 14 common items of day-to-day.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Primary	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).	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Primary	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.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Primary	Compartmental volumes of the rib cage	Analysis of the kinematics of the thoracic wall through the optical-electronic plethysmograph	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	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).	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	Inspiratory muscle strength	Manovacuometry: Maximal Inspiratory pressure (MIP), Measured in centimeters of water	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	Expiratory muscle strength	Manovacuometry: maximal expiratory pressure (MEP), Measured in centimeters of water	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	Diaphragmatic thickness	Measurement of the diaphragmatic thickness from the middle of the pleural line to the middle of the peritoneal line.	Three months total: After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	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.	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)
Secondary	Oxygen Uptake Ef?ciency Slope	The OUES re?ects 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.	Three months total:After 20 sessions of intervention(2 months) and after 1 months without treatment (follow-up)