Clinical Trials Logo

Clinical Trial Summary

The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.


Clinical Trial Description

Purpose/Hypothesis:

Verify the validity and reliability of strain gauge assessment of strength of extensor digitorum brevis (EDB) muscle compared to compound muscle action potential (CMAP) size from EDB and surface electromyography (SEMG) data from EDB after injection of botulinum toxin into EDB

1. Primary Outcome Measure:

Change in measured strength (using strain gauges) of dorsiflexion of digits 3 and 4 ("strength of EDB") after vs. before botulinum toxin injection into EDB

2. Secondary Outcome Measures:

1. Change in CMAP (with standard reference electrode location and with an "inactive" reference electrode location) from EDB after vs. before botulinum toxin injection into EDB;

2. Change in SEMG parameters from EDB, tibialis anterior (TA), and extensor digitorum longus (EDL) after vs. before botulinum toxin injection into EDB

STUDY DESIGN:

1. Overview:

Single intramuscular injection of botulinum toxin or placebo (placebo or BOTOX 2 units or BOTOX 20 units, each with a total volume of 0.1 ml) intramuscular into right EDB on Day 0. Strain gauge data and SEMG data from TA and EDL are obtained at each evaluation time: Baseline (3 separate times prior to Day 0 after at least 5 separate training sessions for the strain gauges); Day 1; Day 2; Day 4 (during anticipated rapid change); Day 14 (+/-1 day) (at clinical nadir); Day 21 (+/-1 day) (another day at clinical nadir); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred); CMAP & SEMG data from EDB are obtained at Baseline; Day 4 (close to nadir of CAMP); Day 14 (at nadir of CAMP) and/or Day 21 (at nadir of CAMP); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred but CMAP should not have recovered).

2. Protocol:

Single-center, Double-Blind, Randomized, Pilot Trial Total Sample Size: 12-15

Treatment Groups:

BOTOX Single Dose 20 units IM in EDB in 0.1 ml BOTOX Single Dose 2 units IM in EDB in 0.1 ml Placebo (Saline) Single Dose IM in EDB in 0.1 ml

Estimated Time to Enroll:

0-3 months

Estimated Study Duration:

4-6 months ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00822523
Study type Interventional
Source Loma Linda University
Contact
Status Completed
Phase N/A
Start date January 2009
Completion date July 2015

See also
  Status Clinical Trial Phase
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT05945641 - Effect of Low-load Resistance Training vs. High-intensity Interval Training on Local Muscle Endurance N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A
Completed NCT03715920 - Comparison of Different Quadriceps Femoris Isometric Strengthening Methods N/A
Terminated NCT01561404 - Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise Phase 4
Completed NCT04535336 - Vitality Acupunch Exercise Program for Older Adults With Sarcopenia N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Recruiting NCT06061315 - Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men N/A
Completed NCT05366348 - The Effects of Horse-back Riding on Core Muscles in Adolescents N/A
Completed NCT04213586 - Effects of Whey Protein and Collagen Supplementation N/A
Completed NCT04626817 - Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study N/A
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT01449097 - Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers Phase 4
Completed NCT05882981 - Increased Femoral Anteversion and Physical Performance
Completed NCT06196268 - Core Strengthening vs Pilates Exercises on Posture, Body Awareness and Fatigue Among Female Athletes N/A
Completed NCT00059436 - Mental Effort and Muscle Strength Phase 1
Recruiting NCT06410014 - Assessment of Overall Functioning in Patients With Complex Health Issues
Completed NCT04315077 - The Short Term Effects of Oceanix Supplementation on Recovery N/A
Completed NCT04239417 - Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty N/A