Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
|ClinicalTrials.gov Identifier: NCT00883142|
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : June 11, 2013
|Condition or disease|
|Spinal Cord Injuries Multiple Sclerosis Stroke|
Description of the Clinical Lokomat Therapy program:
This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20 minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions), 5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and 5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate and blood pressure are monitored by the therapist and recorded. Work performed is measured and recorded in the Lokomat computer for time, speed, amount of weight bearing, and distance.
Description of the Research Component:
A pre and post, prospective study design will be employed. Baseline measurements (Please see below and Table 1 for detailed descriptions) will be performed prior to start of the Lokomat therapy program and then again after completion of the 12-week program. A chart review will be performed at baseline only for documentation of medical history and medications. In a subset of patients a muscle biopsy will be performed for gene expression at baseline and week 12.
As part of Clinical Care, during each of the Lokomat therapy sessions the following information is collected:
- Work (total time, speed, distance, amount of weight bearing)
- Heart rate (HR)
- Blood Pressure (SBP, DBP)
- Perception of exertion (Borg Scale)
- Lipid profile (pre and post)
- Albumin (pre and post)
For Research purposes the following is being proposed:
Review and record work, HR, BP, Borg Scale from all clinical sessions
Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):
- Resting energy expenditure (REE)
- Body Composition [dual energy x-ray absorptiometry (DEXA) ) - [scans include total body, dual femur, and the knee], partial body potassium counting (PBKleg), bioelectrical impedance analysis (BIA), anthropometric and skin fold measurements]
- Fasting blood draw for plasma glucose and insulin (FPG, FPI), lipid profile, testosterone, sex hormone binding globulin (SHBG), insulin-like growth factor 1 (IGF-1), bone markers, coagulation factors, platelet aggregation, 2 hour standard oral glucose tolerance testing (OGTT) with insulin levels.
- Autonomic and blood pressure regulation studies [resting and tilt table provocation, for heart rate and blood pressure variability (HRV, BPV), arterial blood flow, and venous occlusion]
- Disability-specific quality of life (QOL) and activities of daily living surveys [GI-Bowel survey, brief pain inventory (BPI), fatigue survey, spasticity scale, mini mental status exam (MMSE)]. These disease-specific QOLs will include the question "How do you rate your general health and well-being over the past week?" A Lickert scale response will be incorporated.
- Functional Mobility Assessment
- Muscle biopsy for gene expression (subset of patients only).
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||Functional and Physiological Responses to Lokomat Therapy (Pilot Study)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||March 2013|
- This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function [ Time Frame: After completion of 24 clinical Lokomat rehabilitation sessions ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883142
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Ann M. Spungen, EdD||VA Medical Center, Bronx|