Adaptive Sport in Spinal Cord InjuryAdaptive sportNCT02177929
Study About Acting of Adaptive Sport in Musculoskeletal, Cardiovascular System and the Quality of Life of Individuals With Spinal Cord Injury Through Biomedical Instrumentation
A study testing adapted canoeing, hadbike and conventional physiotherapy in people with Adaptive Sport in Spinal Cord Injury, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Adaptive Sport in Spinal Cord Injury
- What is being tested?
- adapted canoeing, hadbike and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Jun 2014
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Vale do Paraíba
São José dos Campos, São Paulo, 12244-000
UNIVAP, (12) 3947-1000
Elizângela Carvalho Abreu, master
About this study
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.
- Conditions
- Adaptive Sport in Spinal Cord Injury
- Being tested
- adapted canoeing, hadbike and conventional physiotherapy
- Keywords
- Spinal cord injury,, adaptive sport,, dynamometry,, electromyography,, force platform.
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted canoeing, hadbike and conventional physiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| adapted canoeing, handbike, conventional physiotherapy | Experimental | Individuals are divided into three groups: one group adapted canoeing, one group of handbike and one grup of conventional physiotherapy. Receives: Other: adapted canoeing, hadbike and conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Data collection for 11 months.
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.
Measured: For 11 months
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.
Measured: 11 months
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.
Measured: 11 months
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.
Measured: 11 months
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.
Measured: 11 months
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.
Measured: 11 months
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.
Measured: 11 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adaptive Sport in Spinal Cord InjuryStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izabela dos Santos Mendes, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177929
- Sponsor's protocol ID
- CAAE: 18353613.0.0000.5503
- Acronym
- Adaptive sport
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02177929
- Acronym / sponsor ID
- Adaptive sport / CAAE: 18353613.0.0000.5503
- Conditions
- Adaptive Sport in Spinal Cord Injury
- Keywords
- Spinal cord injury,, adaptive sport,, dynamometry,, electromyography,, force platform.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adapted canoeing, handbike, conventional physiotherapy | Experimental | Other: adapted canoeing, hadbike and conventional physiotherapyIndividuals are divided into three groups: one group adapted canoeing, one group of handbike and one grup of conventional physiotherapy. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- age over 40 years
- lesion less than 8 months
- above T2 lesions
- musculoskeletal disorders such as deformity
- severe contracture
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 |
|---|---|---|
| adapted canoeing, hadbike and conventional physiotherapyThe 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. | Other | adapted canoeing, handbike, conventional physiotherapy |
Primary outcome
Evaluate of torque
Time frame: Data collection for 11 months.
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
Time frame: For 11 months
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
Time frame: 11 months
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
Time frame: 11 months
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
Time frame: 11 months
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
Time frame: 11 months
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
Time frame: 11 months
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
Time frame: 11 months
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.
1 secondary outcome
Data Analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted canoeing, hadbike and conventional physiotherapy in people with Adaptive Sport in Spinal Cord Injury, run by Universidade do Vale do Paraíba 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 3 inclusion and 12 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 30 Jun 2014. 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 Elizângela Márcia Abreu ((12)981476984, eliz_nasa@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate of torque (time frame: Data collection for 11 months.). The study lists 8 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 30 Jun 2014.