StrokeNCT02736747
Effects of Cryotherapy on Ankle Movements and Gait of Spastic Hemiparetic Subjects
A study testing Cryotherapy in people with Stroke and Muscle Spasticity, run by Carolina Carmona de Alcântara at 1 site in Brazil.
Trial summary
The stroke has been described as the third cause of death and main cause of disability in the worldwide population. About 60% of the survivors are able to walk following the rehabilitation process, however deficits on lower limbs functions often persists in most cases, affecting the gait and functional mobility. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke, Muscle Spasticity
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Mar 2018
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke (last episode of stroke occurred more than 6 months ago)
- Ischemic stroke
- Minimum score on the Mini Mental State Examination, according to the subject's educational level
- Spasticity level between 1 and 4 according to Modified Ashworth Scale for the plantarflexors
- Locomotion capacity of 2 to 4 according to Functional Ambulation Category (FAC).
Who cannot join
- Diabetic peripheral neuropathy
- Adverse reactions to cold
- Intolerance to cold application
- Absence of sensibility to cold
- Diagnostic of Raynaud syndrome
- Ulcers or skin lesions
Show all 13Show fewer
- Severe cardiovascular or peripheral vascular diseases (heart failure, arrhythmias, angina pectoris, and acute myocardial infarction)
- Other neurological or orthopedic diseases
- Toxin bothulinium injection 4 months or sooner
- Cognitive impairments
- Any history of joint or muscle injuries of the lower limbs
- Body mass index (BMI) greater than 28 kg/m²
- Pain during the any experimental procedure.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Immediate Effects of Cryotherapy on Neuromuscular Performance of Ankle Joint and on Gait Pattern of Chronic Spastic Hemiparetic Subjects Post-Stroke
The stroke has been described as the third cause of death and main cause of disability in the worldwide population. About 60% of the survivors are able to walk following the rehabilitation process, however deficits on lower limbs functions often persists in most cases, affecting the gait and functional mobility. In this sense, several interventions are applied in the clinical practice to optimize the functional performance. Cryotherapy is one of the most used techniques aiming to reduce spasticity temporarily, allowing the training of functional tasks, such as walking. The aim of the present study is to evaluate the immediate effects of cryotherapy (ice pack) on neuromuscular performance, proprioception, passive resistance of dorsiflexors and plantarflexors muscles, and also on gait performance in chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in this crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo) will be randomized. Fifteen days of washout period will be considered. The cryotherapy/placebo will be applied on the posterior area of the leg for 20 minutes. Initially Fugl Meyer will be applied. All other assessments will be performed before and after intervention: spasticity level, classified according to Modified Ashworth Scale; temporo-spatial and angular parameters for trunk, hip, knee and ankle during gait, using a motion analysis system (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position sense), passive resistance to stretching, isometric and isokinetic torques during contractions of plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic dynamometer. Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus will be assessed by electromyography during isokinetic dynamometer assessment and gait. The following electromyographic variables will be analyzed: maximum activation amplitude, muscle onset, coactivation index between agonists and antagonists. For statistical analysis, normality (Shapiro Wilk) and homogeneity (Levene) tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures will be applied. Otherwise, non-parametric statistics (Friedman test) will be applied. A significance level of 0.05 will be considered for all statistical tests.
- Conditions
- Stroke, Muscle Spasticity
- Being tested
- Cryotherapy, Placebo
- Keywords
- Stroke, Muscle Spasticity, Cryotherapy, Gait, Muscle Weakness, Proprioception
- Medical subject headings
- Stroke, Muscle Spasticity, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy (ice pack) | Active comparator | A pack with 1000g of crushed ice without air will be placed for 20 consecutive minutes on a pre-delimited rectangular area with dimensions of 25 x 35 cm and will be fixed with a non-compressive elastic band. One strip of plastic paper will encompass the paretic leg of the subjects, avoiding direct contact from the skin with the ice pack. Receives: Other: Cryotherapy |
| Placebo (sand pack) | Placebo comparator | For placebo application, the pack will be filled with 1000g of thin sand, in environmental temperature, so that the pressure exerted will be the same as the ice pack. All other experimental procedures will follow the same protocol as "cryotherapy application". Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in spasticity level
Spasticity level of plantarflexors and dorsiflexors will be classified according to Modified Ashworth Scale.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in angular kinematic variables during gait
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). A motion analysis system (Qualysis AB, Gothenburg, Sweden) will be used for kinematic data collection during gait. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on T4, L2 and bilaterally on the lateral portion of the thighs and legs. Following markers and clusters placement, a static posture (duration: 10 seconds) will be performed with the subjects in orthostatic position. Then dynamic data will be collected during walking in the self-selected comfortable speed (10 trials). The displacement (°) of the joints of the trunk, hip, knee and ankle during heel strike, stance phase and balance phase will be calculated during gait.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in linear kinematic variables during gait
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). A motion analysis system (Qualysis AB, Gothenburg, Sweden) will be used for kinematic data collection during gait. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on T4, L2 and bilaterally on the lateral portion of the thighs and legs. Following markers and clusters placement, a static posture (duration: 10 seconds) will be performed with the subjects in orthostatic position. Then dynamic data will be collected during walking in the self-selected comfortable speed (10 trials) and linear kinematic variables during gait will be analyzed.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in joint sense position (proprioception) during plantarflexion and dorsiflexion
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The joint position sense (proprioception) test will be performed on an isokinetic dynamometer. The participants will be seated and blindfolded. Initially, the dynamometer will move the foot toward references angles (for dorsiflexion or plantarflexion). Then, subjects will be allowed to sense the reference angle for 10 seconds before the ankle is returned passively to the start position. Subsequently, the foot will be moved passively by the dynamometer toward the reference position (for dorsiflexion or plantarflexion), and subjects will press a button in their hand that will stop the machine when they feel the position has been reached. The absolute error (in degrees) will be calculated as the difference between the indicated and reference positions.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in passive resistance of plantarflexors and dorsiflexors
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The assessment of passive resistance for plantarflexion and dorsiflexion muscles will be performed on an isokinetic dynamometer. The equipment will passively move the foot in a series of 6 repetitions in the movements of dorsiflexion and plantar flexion. Both responses to slow and fast passive stretching will be evaluated. Passive torque peak (N.m) of plantarflexors and dorsiflexors of the ankle will be recorded.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in torque during isometric contractions
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The isometric active torques (N.m) generated during plantarflexion and dorsiflexion contractions will be assessed using an isokinetic dynamometer.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in torque during concentric contractions
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The active torques generated (N.m) during plantarflexion and dorsiflexion movements will be assessed using an isokinetic dynamometer.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in torque during eccentric contractions
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The active torques generated (N.m) during plantarflexion and dorsiflexion movements will be assessed using an isokinetic dynamometer.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Change from baseline in electromyography assessment
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). Bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus will be assessed by electromyography concomitantly with isokinetic dynamometer and gait assessments.
Measured: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2017
- Study completionMar 2018 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Carmona de Alcântara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carolina Carmona de Alcântara, Universidade Federal de Sao Carlos
- Investigators
- Thiago L. Russo, PhD, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736747
- Sponsor's protocol ID
- Cryotherapy_LAFIN
- Status last verified
- Aug 2017
- First submitted
- 18 Mar 2016
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Alcantara CC, Blanco J, De Oliveira LM, Ribeiro PFS, Herrera E, Nakagawa TH, Reisman DS, Michaelsen SM, Garcia LC, Russo TL. Cryotherapy reduces muscle hypertonia, but does not affect lower limb strength or gait kinematics post-stroke: a randomized controlled crossover study. Top Stroke Rehabil. 2019 May;26(4):267-280. doi: 10.1080/10749357.2019.1593613.
PubMed 31012824
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Cryotherapy on Neuromuscular Performance of Ankle Joint and on Gait Pattern of Chronic Spastic Hemiparetic Subjects Post-Stroke
- ClinicalTrials.gov ID
- NCT02736747
- Acronym / sponsor ID
- Cryotherapy_LAFIN
- Conditions
- Stroke, Muscle Spasticity
- Keywords
- Stroke, Muscle Spasticity, Cryotherapy, Gait, Muscle Weakness, Proprioception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Carolina Carmona de AlcântaraUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Mar 2018 (estimated)
- First posted
- 13 Apr 2016 (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 stroke has been described as the third cause of death and main cause of disability in the worldwide population. About 60% of the survivors are able to walk following the rehabilitation process, however deficits on lower limbs functions often persists in most cases, affecting the gait and functional mobility. In this sense, several interventions are applied in the clinical practice to optimize the functional performance. Cryotherapy is one of the most used techniques aiming to reduce spasticity temporarily, allowing the training of functional tasks, such as walking. The aim of the present study is to evaluate the immediate effects of cryotherapy (ice pack) on neuromuscular performance, proprioception, passive resistance of dorsiflexors and plantarflexors muscles, and also on gait performance in chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in this crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo) will be randomized. Fifteen days of washout period will be considered. The cryotherapy/placebo will be applied on the posterior area of the leg for 20 minutes. Initially Fugl Meyer will be applied. All other assessments will be performed before and after intervention: spasticity level, classified according to Modified Ashworth Scale; temporo-spatial and angular parameters for trunk, hip, knee and ankle during gait, using a motion analysis system (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position sense), passive resistance to stretching, isometric and isokinetic torques during contractions of plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic dynamometer. Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus will be assessed by electromyography during isokinetic dynamometer assessment and gait. The following electromyographic variables will be analyzed: maximum activation amplitude, muscle onset, coactivation index between agonists and antagonists. For statistical analysis, normality (Shapiro Wilk) and homogeneity (Levene) tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures will be applied. Otherwise, non-parametric statistics (Friedman test) will be applied. A significance level of 0.05 will be considered for all statistical tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy (ice pack) | Active comparator | Other: CryotherapyA pack with 1000g of crushed ice without air will be placed for 20 consecutive minutes on a pre-delimited rectangular area with dimensions of 25 x 35 cm and will be fixed with a non-compressive elastic band. One strip of plastic paper will encompass the paretic leg of the subjects, avoiding direct contact from the skin with the ice pack. |
| Placebo (sand pack) | Placebo comparator | Other: PlaceboFor placebo application, the pack will be filled with 1000g of thin sand, in environmental temperature, so that the pressure exerted will be the same as the ice pack. All other experimental procedures will follow the same protocol as "cryotherapy application". |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke (last episode of stroke occurred more than 6 months ago)
- Ischemic stroke
- Minimum score on the Mini Mental State Examination, according to the subject's educational level
- Spasticity level between 1 and 4 according to Modified Ashworth Scale for the plantarflexors
- Locomotion capacity of 2 to 4 according to Functional Ambulation Category (FAC).
Key exclusion criteria (13 listed)
- Diabetic peripheral neuropathy
- Adverse reactions to cold
- Intolerance to cold application
- Absence of sensibility to cold
- Diagnostic of Raynaud syndrome
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 |
|---|---|---|
| Cryotherapy | Other | Cryotherapy (ice pack) |
| Placebo | Other | Placebo (sand pack) |
Primary outcome
Change from baseline in spasticity level
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
Spasticity level of plantarflexors and dorsiflexors will be classified according to Modified Ashworth Scale.
Change from baseline in angular kinematic variables during gait
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). A motion analysis system (Qualysis AB, Gothenburg, Sweden) will be used for kinematic data collection during gait. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on T4, L2 and bilaterally on the lateral portion of the thighs and legs. Following markers and clusters placement, a static posture (duration: 10 seconds) will be performed with the subjects in orthostatic position. Then dynamic data will be collected during walking in the self-selected comfortable speed (10 trials). The displacement (°) of the joints of the trunk, hip, knee and ankle during heel strike, stance phase and balance phase will be calculated during gait.
Change from baseline in linear kinematic variables during gait
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). A motion analysis system (Qualysis AB, Gothenburg, Sweden) will be used for kinematic data collection during gait. Passive reflective markers will be placed on the anatomical landmarks (anatomical markers) according to the International Society of Biomechanics. In addition, clusters will be placed on T4, L2 and bilaterally on the lateral portion of the thighs and legs. Following markers and clusters placement, a static posture (duration: 10 seconds) will be performed with the subjects in orthostatic position. Then dynamic data will be collected during walking in the self-selected comfortable speed (10 trials) and linear kinematic variables during gait will be analyzed.
Change from baseline in joint sense position (proprioception) during plantarflexion and dorsiflexion
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The joint position sense (proprioception) test will be performed on an isokinetic dynamometer. The participants will be seated and blindfolded. Initially, the dynamometer will move the foot toward references angles (for dorsiflexion or plantarflexion). Then, subjects will be allowed to sense the reference angle for 10 seconds before the ankle is returned passively to the start position. Subsequently, the foot will be moved passively by the dynamometer toward the reference position (for dorsiflexion or plantarflexion), and subjects will press a button in their hand that will stop the machine when they feel the position has been reached. The absolute error (in degrees) will be calculated as the difference between the indicated and reference positions.
Change from baseline in passive resistance of plantarflexors and dorsiflexors
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The assessment of passive resistance for plantarflexion and dorsiflexion muscles will be performed on an isokinetic dynamometer. The equipment will passively move the foot in a series of 6 repetitions in the movements of dorsiflexion and plantar flexion. Both responses to slow and fast passive stretching will be evaluated. Passive torque peak (N.m) of plantarflexors and dorsiflexors of the ankle will be recorded.
Change from baseline in torque during isometric contractions
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The isometric active torques (N.m) generated during plantarflexion and dorsiflexion contractions will be assessed using an isokinetic dynamometer.
Change from baseline in torque during concentric contractions
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The active torques generated (N.m) during plantarflexion and dorsiflexion movements will be assessed using an isokinetic dynamometer.
Change from baseline in torque during eccentric contractions
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). The active torques generated (N.m) during plantarflexion and dorsiflexion movements will be assessed using an isokinetic dynamometer.
Change from baseline in electromyography assessment
Time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)
The post-evaluation will be performed immediately after the end of the intervention (cryotherapy or placebo, applied for 20 minutes). Bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus will be assessed by electromyography concomitantly with isokinetic dynamometer and gait assessments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 31012824Alcantara CC, Blanco J, De Oliveira LM, Ribeiro PFS, Herrera E, Nakagawa TH, Reisman DS, Michaelsen SM, Garcia LC, Russo TL. Cryotherapy reduces muscle hypertonia, but does not affect lower limb strength or gait kinematics post-stroke: a randomized controlled crossover study. Top Stroke Rehabil. 2019 May;26(4):267-280. doi: 10.1080/10749357.2019.1593613.
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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.
Thiago L. Russo, PhD principal investigator
Universidade Federal de Sao 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 Cryotherapy in people with Stroke and Muscle Spasticity, run by Carolina Carmona de Alcântara 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 5 inclusion and 13 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 2 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in spasticity level (time frame: baseline, 20 minutes (immediately post-application of cryotherapy or placebo)). The study lists 9 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 NCT02736747, 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 2 Aug 2017.