High-Intensity, Dynamic-stability Gait Training in People With Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMarquette University
About this trial
The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis. This trial involves intense exercise combined with walking on a shaky treadmill. Walking on a shaky treadmill helps to practice balance and intense exercise promotes the ability to walk faster and farther. In this study, participants will train with a combination of high or low intensity, and with a stable or shaky treadmill. Walking speed and endurance, balance while walking and the number of steps taken in the community will be measured before, half way through the training (15 sessions), after training (30 sessions) and six months after training.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have a clinical diagnosis of MS according to the revised McDonald Criteria. Participants with an EDSS score of 2.0-6.5 will be included but must have a stable disease course without worsening more than 1.0 EDSS point over the last 3 months and no MS exacerbation within the preceding 4 weeks, as determined by interview and review of medical records.
Participants will have stable MS disease treatments. All medications will be consistent for at least 1 month prior to enrollment. No corticosteroids for at least 1 month and no botulinum toxin injections above the knee for at least 3 months prior to enrollment.
Participants will be between the age of 18 and 65 and have a body mass of less than 135kg (maximum mass for treadmill equipment).
Participants will be able to follow three commands, as determined by the three step command test of the Mini Mental State Exam.
Disqualifiers
None
Trial design
Design model
Factorial
Treatments tested in this trial
High-Intensity Treadmill Training
Procedure/SurgeryParticipants will walk on a treadmill at a speed that produces 70-80% of age-adjusted heart rate reserve or a rating of perceived exertion of 17/20. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.
Treadmill Training with Perturbations
Procedure/SurgeryParticipants will walk on a treadmill and a perturbation of the treadmill will be produced every 20s. Perturbations will randomly occur in the forward, backward, right or left directions, with a perturbation size set to 80% of stability threshold. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts with 2-3 minutes rest between bouts.
Standard Treadmill Training
Procedure/SurgeryParticipants will walk on a treadmill at a speed that produces 30-40% of age-adjusted heart rate reserve. A total of 30, one hour sessions will be conducted. Training will be conducted in 10 minute bouts, with 2-3 minutes rest between bouts.
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: High-Intensity With PertubationsExperimental treatment 2 interventions
Group B: High-Intensity No PerturbationsExperimental treatment 1 intervention
Group C: Moderate-Intensity With PerturbationsExperimental treatment 2 interventions
Group D: Moderate-Intensity No PerturbationsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in Timed 25-foot walk test
Gait speed will be measured using the timed 25-foot walk test. The test consists of walking 25 feet along a clearly marked walkway as quickly as possible while maintaining safety, using devices as needed. The task is repeated as the patient walks back the same distance. The average of the two trials is used as a measure of gait speed.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions2
Changes in 6-minute walk test
The 6 minute walk test consists of a measurement of the distance walked in 6 minutes, using a walkway of at least 12 meters, with cones demarcating the turnaround points and instructions to walk as fast and as far as possible.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions3
Changes in Functional Gait Assessment (FGA)
The FGA measures dynamic balance during walking using a series of 10 tasks, with each item rated on a scale of 0-3 (maximum score = 30). Test components include walking on a level surface at normal pace with changes in gait speed, head turns, obstacle and narrow path negotiation, and on stairs.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions4
Changes in Daily stepping activity
Daily stepping activity will be obtained using the StepWatch (Modus, Washington DC), which is an ankle-worn accelerometer that has demonstrated the best accuracy of all commercial accelerometers. Data are collected in 1 min increments with daily stepping activity as the primary variable. Data will be collected for 7 days at each evaluation period.
Time frame
Before training, 1-2 weeks after all training sessions, 6 months after all training sessionsSecondary outcomes
1
Changes in Peak treadmill speed and cardiorespiratory fitness
VO2peak and VO2gain ml/mg/min will be assessed during graded treadmill testing. Participants will walk at 0.1 m/s for 1 min, with speed increased by 0.1 m/s every minute. Metabolic data will be collected on a breath-by-breath basis until treadmill testing is terminated, as determined by loss of balance, patient intolerance, or abnormal ECG recording consistent with absolute contraindications to continue testing. The averaged VO2 during the final minute of treadmill testing at peak speed will be determined (VO2peak). Baseline VO2peak and VO2 at the matched speed Post-training (VO2match) will be used to identify changes in metabolic efficiency. The difference between gains in VO2peak and VO2match will be identified as VO2 gain.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions2
Changes in Berg Balance Scale
The Berg Balance Scale (BBS) will be used to assess standing balance and determine whether walking balance training carries over to standing balance. The BBS consists of 14 static and dynamic balance tasks of varying difficulty, rated on a scale of 0-4 by an assessor (max score = 56).
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions3
Changes in Falls incidence
A survey of Falls incidence will be administered at Baseline to estimate the number of falls in the past 6 months. At this time, participants will be issued a journal to document falls for the duration of the training study and for 6 months after training has been completed. Study staff will contact participants every month to assure compliance.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessions4
Changes in Kinematic Response to unexpected perturbations
Responses to 5 magnitudes of perturbations of the treadmill in 4 directions will be measured using a whole body motion capture. Center of Mass movement and foot placement (Base of Support) will be calculated and medial/lateral margin of stability and anterior/posterior dynamic gait stability will be used to assess the response. Step sizes and trunk angles will be quantified.
Time frame
Before training, 5-6 weeks after training begins, 1-2 weeks after all training sessions, 6 months after all training sessionsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marquette University
Lead sponsor
Indiana University
Collaborator
Medical College of Wisconsin
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov