Limited evidence is available regarding the quantitative effects of Botox® on energy expenditure as measured by oxygen consumption during functional gait. The purpose of this study is to measure metabolic energy expenditures and determine its relationship to the changes in spasticity and gait after botulinum toxin type A. Dynamic EMG will be used to quantify muscle over activity, direct therapy and assess efficacy of treatment. Oxygen consumption will be measured using a portable metabolic system. Other measures to be used to assess spasticity will be the pendulum drop test when quadriceps hyperactivity is present and the standard clinical modified Ashworth score. Gait will be measured using a 3D motion analysis system, resulting in symmetry indices of the temporal spatial measures and joint angle excursions. KMRREC's Human Performance and Movement Analysis Lab (HPMAL) has collected pilot data showing the value of EMG-guided gait analysis system in identifying spastic muscles requiring Botox® injections with resulting improvement in gait. In addition, pilot data from the HPMAL has demonstrated decreased excursion in the center of gravity post spasticity treatment with botulinum toxin type A injection. Results from this study could provide pilot data relative to the functional benefit of Botox® for unilateral lower limb spasticity and the energy cost benefit of this intervention that would be useful in applying for larger NIH grants.
Purpose: The purpose of this pilot study is to determine the effects of botulinum toxin type A injections (Botox®) on the reduction of unilateral lower limb spasticity, gait performance and oxygen consumption in patients with TBI and ABI.
Primary Objectives: The objectives of this study are to determine the effects of Botox® on unilateral lower limb spasticity as they relate to:
1. changes in spasticity as measured by dynamic EMG during gait, pendulum drop test and the modified Ashworth scores;
2. changes in oxygen consumption during gait as measured by a portable metabolic system;
3. changes in temporal spatial gait symmetry as measured by a 3D motion analysis system;
4. changes in symmetry of joint angle excursions during gait as measured by a 3D motion analysis system;
5. changes in function and quality of life outcomes as measured by the Medical Outcome Survey (SF-36).
Registry Project Number: 284
Lead Investigator: Elovic, E
Lead Center for Project: Kessler Medical Rehabilitation Research and Education Corporation
Collaborating Investigators: Beng, J, Bond, Q
Keywords: medication, traumatic brain injury
Date of Completion: 09/30/2002
Status of Project: Latest Information Shown
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