Back to resultsStudy About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation (Adaptive sport)
Primary Purpose
Adaptive Sport in Spinal Cord Injury
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
adapted canoeing, hadbike and conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Adaptive Sport in Spinal Cord Injury focused on measuring Spinal cord injury,, adaptive sport,, dynamometry,, electromyography,, force platform.
Eligibility Criteria
Inclusion Criteria:
- aged 15-40 years
- of both sexes
- with injury time over 8 months, who present spasticity in the lower limbs up to grade 2 according to the scale of Ashwoth modified patient with paraplegia or paraparesis in thoracolumbar level (lower than T2) levels.
Exclusion Criteria:
- age over 40 years
- lesion less than 8 months
- above T2 lesions
- musculoskeletal disorders such as deformity
- severe contracture
- previously diagnosed cardiovascular abnormalities or risk factors such as hypertension
- diabetes and obesity, use of medications and cardiopressant cardioestimuladoras, smoking and alcoholics.
For individuals who participate in the group canoeing and by adapting the pool will still include the following exclusion criteria:
- decubitus ulcers
- fungal infections
- urinary incontinence
- inflammatory processes and neoplasms.
Sites / Locations
- Universidade do Vale do ParaíbaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adapted canoeing, handbike, conventional physiotherapy
Arm Description
Individuals are divided into three groups: one group adapted canoeing, one group of handbike and one grup of conventional physiotherapy.
Outcomes
Primary Outcome Measures
Evaluate of torque
The isokinetic dynamometer Biodex System will be used to evaluate the torque of biceps and triceps brachii of the dominant limb. The protocol will be conducted in 5 replicates in concentric isokinetic mode for flexion and extension of the elbow. The range of motion is from 80 to elbow extension, adopting as the 0 ° position in which the longitudinal center line of the lever arm of the dynamometer will remain parallel to the ground. The forearm of individuals remain in neutral pronation-supination, the shoulder joint is maintained at 45 ° of flexion and abduction. The unit of measure will be N.m
Evaluation of resistance to stretching of the flexors and extensors knee
Individuals will be submitted to test resistance to stretching of the flexors and extensors knee of the dominant leg, through isokinetic dynamometer Biodex System. To perform the test the individual remain seated and stabilized in equipment with hip and knee flexed to 90°. The lever arm is positioned at 2 cm from the malleoli (medial and lateral) axes of the ankle and the dynamometer coincide with the axis of movement of flexion-extension of the knee. After positioning, the dynamometer in passive mode will be triggered to perform 5 repetitions of knee flexion-extension in an angular velocity of 120 °/s, and range of motion of 90°. Individuals will be instructed not to perform any kind of contraction or voluntary movement. The unit of measure is N.m.
Electromyography of knee extensors
Simultaneously, the evaluation of the tone of the lower limbs through dynamometry muscle activity will be captured by means of EMG. Electromyographic variables are captured in relation to the quadriceps muscle group of the dominant limb. Surface electrodes are placed on the muscle belly of the rectus femoris, vastus medialis and vastus lateralis according to the recommendations of SENIAM (Surface Electro MyoGraphy for the Non-Invasive Assessment of Muscles). The EMG signal is acquired with a sampling frequency of 2000 Hz and unit reader of channels in microvolts. The data are normalized by the average of electromyographic signals during passive movement performed by isokinetic dynamometer.
Electromyography of erector trunk
Electromyographic variables are also captured in relation to the erector muscles of the trunk. Surface electrodes are placed on the muscle belly (bilaterally), 2 cm from the vertebra, corresponding to one segment above the level of the lesion for each group analyzed point. The EMG signal is acquired with a sampling frequency of 2000 Hz and unit reader of channels in microvolts. The data are normalized by the average of electromyographic signals obtained during the stabilization of the trunk through the force platform test, described below.
Evaluation of trunk balance
Simultaneously, the EMG of the erector muscles of the trunk, the trunk balance will be assessed using a force platform, EMG system brand in Brazil, which has four load cells and acquisition frequency of 2000 Hz This platform analyzes anteroposterior oscillation. In the evaluation, patients remain in sitting under the platform with outstanding lower limbs and upper limbs along the body for 30 seconds with eyes open and then with eyes closed position. The unit of measure will be Kgf.
kinematic analysis
To analyze the movements of the upper limbs markers will be fixed in the following anatomical landmarks: lateral center of the shoulder joint, lateral trunk, elbow, wrist and fifth metacarpal head of the dominant limb. The regions where the markers will be fixed previously cleaned with cotton and alcohol to remove the natural oils from the skin, allowing for better fixation of the markers. The videos will be played during activities of canoeing and handbike so adapted to the collection. The video camera will be positioned laterally to the individual. For canoeing gathering will be held at the clinic hydrotherapy and movement of boating pool is played similarly for 2 min, with guy in kayak. And for analyzing the movements performed for handbike, subjects will be shot while performing movements with handbike on a roll for 2 minutes. The joint angles of the shoulder, elbow and wrist, and the pace of movement will be analyzed.
Analysis of heart rate varibilidade
Data will be collected through the heart monitor Polar RS 800 then will be transferred to a microcomputer equipped with Polar ProTrainer software. The signal will be filtered and exported to Matlab 6.1 to perform the Continuous Wavelet Transform (TWC) in order to obtain for the spectral analysis variables: low frequency - LF = Low Frequency, 0.04-0.15 Hz and high frequency - HF = High Frequence, 0.15-0.4 Hz; and a temporal analysis variables: HR, RR, SDNN, RMSSD and PNN50.
Evaluation of quality of life
To assess the quality of life questionnaire World Health Organization Quality of Life in its shortened version - WHQOL-BREF is used. This instrument consists of 26 questions, of which 24 are divided into four domains: physical, psychological, social relationships and environment, in addition to these four areas, the instrument features two general questions: one refers to the perception of quality of life and other satisfaction with health. All responses are composed of graduated scale with scores ranging from one to five points.
Secondary Outcome Measures
Data Analysis
For data analysis, dynamometry and electromyography (EMG) is used to EMGworks Program 3.1.1.1 Analysis of Delsys.
To dynamometry, delete the first and last repetition and will be calculated for the mean peak torque of upper limb and root mean square (RMS - English root mean square) for resistance to passive movement of the lower limb. For electromyographic analysis, will be using a 4th order bandpass filter (20-400 Hz) and the RMS value is calculated for each signal.
The heart rate variability will be analyzed by Wavelet raw state.
For data analysis of quality of life an application Excel is used.
For the remaining data will be given on how best analysis.
The statistical analysis will be performed using the program Bioestat
Full Information
NCT ID
NCT02177929
First Posted
June 18, 2014
Last Updated
June 26, 2014
Sponsor
Universidade do Vale do Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT02177929
Brief Title
Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
Acronym
Adaptive sport
Official Title
Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Paraíba
4. Oversight
5. Study Description
Brief Summary
The hypothesis is to the fulfillment of canoeing, handbike and conventional physiotherapy activities the groups could show improvement in muscle strength of the arms, decreased resistance of the lower limbs (spasticity), improved trunk balance and movements of the upper limbs, improves cardiovascular function, bone health, and consequently improve the quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adaptive Sport in Spinal Cord Injury
Keywords
Spinal cord injury,, adaptive sport,, dynamometry,, electromyography,, force platform.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adapted canoeing, handbike, conventional physiotherapy
Arm Type
Experimental
Arm Description
Individuals are divided into three groups: one group adapted canoeing, one group of handbike and one grup of conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
adapted canoeing, hadbike and conventional physiotherapy
Intervention Description
The subjects adapted canoeing group will practice on the kayak and rowing exercises associating with ball.
The individuals in the group will handbike workouts outdoors and surpassing cirucuitos mounted with cones.
Individuals in the conventional physiotherapy group will make stretching and strengthening exercises.
Primary Outcome Measure Information:
Title
Evaluate of torque
Description
The isokinetic dynamometer Biodex System will be used to evaluate the torque of biceps and triceps brachii of the dominant limb. The protocol will be conducted in 5 replicates in concentric isokinetic mode for flexion and extension of the elbow. The range of motion is from 80 to elbow extension, adopting as the 0 ° position in which the longitudinal center line of the lever arm of the dynamometer will remain parallel to the ground. The forearm of individuals remain in neutral pronation-supination, the shoulder joint is maintained at 45 ° of flexion and abduction. The unit of measure will be N.m
Time Frame
Data collection for 11 months.
Title
Evaluation of resistance to stretching of the flexors and extensors knee
Description
Individuals will be submitted to test resistance to stretching of the flexors and extensors knee of the dominant leg, through isokinetic dynamometer Biodex System. To perform the test the individual remain seated and stabilized in equipment with hip and knee flexed to 90°. The lever arm is positioned at 2 cm from the malleoli (medial and lateral) axes of the ankle and the dynamometer coincide with the axis of movement of flexion-extension of the knee. After positioning, the dynamometer in passive mode will be triggered to perform 5 repetitions of knee flexion-extension in an angular velocity of 120 °/s, and range of motion of 90°. Individuals will be instructed not to perform any kind of contraction or voluntary movement. The unit of measure is N.m.
Time Frame
For 11 months
Title
Electromyography of knee extensors
Description
Simultaneously, the evaluation of the tone of the lower limbs through dynamometry muscle activity will be captured by means of EMG. Electromyographic variables are captured in relation to the quadriceps muscle group of the dominant limb. Surface electrodes are placed on the muscle belly of the rectus femoris, vastus medialis and vastus lateralis according to the recommendations of SENIAM (Surface Electro MyoGraphy for the Non-Invasive Assessment of Muscles). The EMG signal is acquired with a sampling frequency of 2000 Hz and unit reader of channels in microvolts. The data are normalized by the average of electromyographic signals during passive movement performed by isokinetic dynamometer.
Time Frame
11 months
Title
Electromyography of erector trunk
Description
Electromyographic variables are also captured in relation to the erector muscles of the trunk. Surface electrodes are placed on the muscle belly (bilaterally), 2 cm from the vertebra, corresponding to one segment above the level of the lesion for each group analyzed point. The EMG signal is acquired with a sampling frequency of 2000 Hz and unit reader of channels in microvolts. The data are normalized by the average of electromyographic signals obtained during the stabilization of the trunk through the force platform test, described below.
Time Frame
11 months
Title
Evaluation of trunk balance
Description
Simultaneously, the EMG of the erector muscles of the trunk, the trunk balance will be assessed using a force platform, EMG system brand in Brazil, which has four load cells and acquisition frequency of 2000 Hz This platform analyzes anteroposterior oscillation. In the evaluation, patients remain in sitting under the platform with outstanding lower limbs and upper limbs along the body for 30 seconds with eyes open and then with eyes closed position. The unit of measure will be Kgf.
Time Frame
11 months
Title
kinematic analysis
Description
To analyze the movements of the upper limbs markers will be fixed in the following anatomical landmarks: lateral center of the shoulder joint, lateral trunk, elbow, wrist and fifth metacarpal head of the dominant limb. The regions where the markers will be fixed previously cleaned with cotton and alcohol to remove the natural oils from the skin, allowing for better fixation of the markers. The videos will be played during activities of canoeing and handbike so adapted to the collection. The video camera will be positioned laterally to the individual. For canoeing gathering will be held at the clinic hydrotherapy and movement of boating pool is played similarly for 2 min, with guy in kayak. And for analyzing the movements performed for handbike, subjects will be shot while performing movements with handbike on a roll for 2 minutes. The joint angles of the shoulder, elbow and wrist, and the pace of movement will be analyzed.
Time Frame
11 months
Title
Analysis of heart rate varibilidade
Description
Data will be collected through the heart monitor Polar RS 800 then will be transferred to a microcomputer equipped with Polar ProTrainer software. The signal will be filtered and exported to Matlab 6.1 to perform the Continuous Wavelet Transform (TWC) in order to obtain for the spectral analysis variables: low frequency - LF = Low Frequency, 0.04-0.15 Hz and high frequency - HF = High Frequence, 0.15-0.4 Hz; and a temporal analysis variables: HR, RR, SDNN, RMSSD and PNN50.
Time Frame
11 months
Title
Evaluation of quality of life
Description
To assess the quality of life questionnaire World Health Organization Quality of Life in its shortened version - WHQOL-BREF is used. This instrument consists of 26 questions, of which 24 are divided into four domains: physical, psychological, social relationships and environment, in addition to these four areas, the instrument features two general questions: one refers to the perception of quality of life and other satisfaction with health. All responses are composed of graduated scale with scores ranging from one to five points.
Time Frame
11 months
Secondary Outcome Measure Information:
Title
Data Analysis
Description
For data analysis, dynamometry and electromyography (EMG) is used to EMGworks Program 3.1.1.1 Analysis of Delsys.
To dynamometry, delete the first and last repetition and will be calculated for the mean peak torque of upper limb and root mean square (RMS - English root mean square) for resistance to passive movement of the lower limb. For electromyographic analysis, will be using a 4th order bandpass filter (20-400 Hz) and the RMS value is calculated for each signal.
The heart rate variability will be analyzed by Wavelet raw state.
For data analysis of quality of life an application Excel is used.
For the remaining data will be given on how best analysis.
The statistical analysis will be performed using the program Bioestat
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 15-40 years
of both sexes
with injury time over 8 months, who present spasticity in the lower limbs up to grade 2 according to the scale of Ashwoth modified patient with paraplegia or paraparesis in thoracolumbar level (lower than T2) levels.
Exclusion Criteria:
age over 40 years
lesion less than 8 months
above T2 lesions
musculoskeletal disorders such as deformity
severe contracture
previously diagnosed cardiovascular abnormalities or risk factors such as hypertension
diabetes and obesity, use of medications and cardiopressant cardioestimuladoras, smoking and alcoholics.
For individuals who participate in the group canoeing and by adapting the pool will still include the following exclusion criteria:
decubitus ulcers
fungal infections
urinary incontinence
inflammatory processes and neoplasms.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizângela Márcia Abreu
Phone
(12)981476984
Email
eliz_nasa@yahoo.com.br
Facility Information:
Facility Name
Universidade do Vale do Paraíba
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12244-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UNIVAP
Phone
(12) 3947-1000
First Name & Middle Initial & Last Name & Degree
Elizângela Carvalho Abreu, master
12. IPD Sharing Statement
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Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
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