NCT01153022

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

May 12, 2010

Last Update Submit

June 28, 2010

Conditions

Keywords

Musculoskeletal manipulationsMuscle spasticity

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

Interventions

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAM

Manizales, Caldas Department, Colombia

Location

MeSH Terms

Conditions

Muscle SpasticitySpinal Cord InjuriesStrokeCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Julio E Pérez, Master

    Universidad Autónoma de Manizales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

June 29, 2010

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations