Muscle SpasticityJM-HRreflexNCT01153022
Effect of Joint Mobilization on Alpha Motoneuron Reflex Excitability
A study testing joint mobilization techniques in people with Muscle Spasticity and Spinal Cord Injury, run by Universidad Autónoma de Manizales, Colombia at 1 site in Colombia.
Trial summary
Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex excitability of the soleus muscle in people with spasticity. Subjects and Methods: A controlled clinical trial with crossover design and simple masking was conducted in 24 randomized subjects to initiate the control or… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Spasticity, Spinal Cord Injury, Stroke
- What is being tested?
- joint mobilization techniques
- How many people
- 24 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2008to Mar 2009
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- people over 18 years old
- spasticity acquired after five years of age
- any etiology
- any location of the injury
- Patients were instructed not to consume coffee, cigarettes or energy drinks 24 hours prior to the study nor participate in excessive physical exercise during the day.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Joint Mobilization on Alpha Motoneuron Reflex Excitability in People With Spasticity: Controlled Clinical Trial
Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex excitability of the soleus muscle in people with spasticity.
Subjects and Methods: A controlled clinical trial with crossover design and simple masking was conducted in 24 randomized subjects to initiate the control or experimental group. Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex - H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to basal measurement. For each measurement a hypothesis test was performed (Student t test).
Read more
Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury (ISCI), a significant difference was found between measurements of both studies, concerning variation in alpha motoneuron reflex excitability during the application of joint mobilization techniques, with a decrease in the experimental group and an increase in the control group. In contrast, no significant differences were found after mobilization therapy. Patients with complete spinal cord injury (CSCI) showed no significant differences in any measurements.
Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect after completion of the trial. This research project showed no evidence regarding spasticity reduction in complete spinal cord injuries. This suggests that therapeutic interventions to decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should be reconsidered.
- Conditions
- Muscle Spasticity, Spinal Cord Injury, Stroke, Craniocerebral Trauma
- Being tested
- joint mobilization techniques
- Keywords
- Musculoskeletal manipulations, Muscle spasticity
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries, Stroke, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint mobilization techniquesOther
In the experimental group, ankle joint mobilization was applied for five minutes, using grade II joint traction rhythmic oscillation (Mailland Scale) with the knee in 15° of flexion, subtalar in neutral and ankle in resting position (10º plantarflexion). During the control study, participants were placed under the same conditions as those of the experimental group but only the hands of the evaluator were placed in the foot, in the position of joint traction simulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
H reflex
The Hoffmann reflex is an electrically induced reflex, analogous to the myotatic reflex that is mechanically triggered by stretching the neuromuscular spindle. In contrast, the H reflex stimulates the Ia fiber at the peripheral nerve level.
Measured: Twelve measurements were performed for each patient: basal rate (0), during joint mobilization (1, 3 and 5 minutes) and after the completion of joint mobilization (1, 3, 5, 10, 15, 20, 25 and 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Manizales, Colombia
- Sponsor type
- University, hospital or other
- Investigators
- Julio E Pérez, Master, Principal investigator, Universidad Autónoma de Manizales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153022
- Sponsor's protocol ID
- CT01UAM-H reflex
- Acronym
- JM-HRreflex
- Status last verified
- Jun 2010
- First submitted
- 12 May 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Joint Mobilization on Alpha Motoneuron Reflex Excitability in People With Spasticity: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01153022
- Acronym / sponsor ID
- JM-HRreflex / CT01UAM-H reflex
- Conditions
- Muscle Spasticity, Spinal Cord Injury, Stroke, Craniocerebral Trauma
- Keywords
- Musculoskeletal manipulations, Muscle spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad Autónoma de Manizales, ColombiaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Jun 2010 (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.
Objective: To determine the effect of ankle joint mobilization on the alpha motoneuron reflex excitability of the soleus muscle in people with spasticity.
Subjects and Methods: A controlled clinical trial with crossover design and simple masking was conducted in 24 randomized subjects to initiate the control or experimental group. Traction and rhythmic oscillation were applied for five minutes to the ankle joint. Alpha motoneuron reflex excitability was assessed by measuring H wave amplitude (Hoffmann reflex - H reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in the soleus muscle. In each subject 12 measurements were taken: basal rate, during and after mobilization. Changes in alpha motoneuron reflex excitability were calculated in relation to basal measurement. For each measurement a hypothesis test was performed (Student t test).
Results: In groups of patients with brain injury (BI) and incomplete spinal cord injury (ISCI), a significant difference was found between measurements of both studies, concerning variation in alpha motoneuron reflex excitability during the application of joint mobilization techniques, with a decrease in the experimental group and an increase in the control group. In contrast, no significant differences were found after mobilization therapy. Patients with complete spinal cord injury (CSCI) showed no significant differences in any measurements.
Conclusion: We demonstrate the effectiveness of passive movement in the decrease of muscle tone during the mobilization maneuver in patients with BI or ISCI, but no residual effect after completion of the trial. This research project showed no evidence regarding spasticity reduction in complete spinal cord injuries. This suggests that therapeutic interventions to decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should be reconsidered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- people over 18 years old
- spasticity acquired after five years of age
- any etiology
- any location of the injury
- Patients were instructed not to consume coffee, cigarettes or energy drinks 24 hours prior to the study nor participate in excessive physical exercise during the day.
Key exclusion criteria (0 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 |
|---|---|---|
| joint mobilization techniquesIn the experimental group, ankle joint mobilization was applied for five minutes, using grade II joint traction rhythmic oscillation (Mailland Scale) with the knee in 15° of flexion, subtalar in neutral and ankle in resting position (10º plantarflexion). During the control study, participants were placed under the same conditions as those of the experimental group but only the hands of the evaluator were placed in the foot, in the position of joint traction simulation. | Other | – |
Primary outcome
H reflex
Time frame: Twelve measurements were performed for each patient: basal rate (0), during joint mobilization (1, 3 and 5 minutes) and after the completion of joint mobilization (1, 3, 5, 10, 15, 20, 25 and 30 minutes)
The Hoffmann reflex is an electrically induced reflex, analogous to the myotatic reflex that is mechanically triggered by stretching the neuromuscular spindle. In contrast, the H reflex stimulates the Ia fiber at the peripheral nerve level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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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.
Julio E Pérez, Master principal investigator
Universidad Autónoma de Manizales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint mobilization techniques in people with Muscle Spasticity and Spinal Cord Injury, run by Universidad Autónoma de Manizales, Colombia at 1 site in Colombia.
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 0 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: finished, as of the sponsor's last update on 29 Jun 2010. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
H reflex (time frame: Twelve measurements were performed for each patient: basal rate (0), during joint mobilization (1, 3 and 5 minutes) and after the completion of joint mobilization (1, 3, 5, 10, 15, 20, 25 and 30 minutes)). 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 29 Jun 2010.