Clinical trial NCT01992679: Body Weight Supported Treadmill Training in Persons With Multiple Sclerosis
Official title: Body Weight Supported Treadmill Training in Advanced Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is growing evidence that exercise-based rehabilitation results in improvements in mobility and participation in persons with multiple sclerosis (MS). However, the vast majority of the scientific evidence in support of this view is based on persons with MS who have minimal mobility impairment. This is partially due to the lack of accessible exercise equipment and facilities available to persons with severe mobility limitations.

One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

Detailed description: One option available to persons with severe mobility limitations is body weight supported treadmill training. Indeed, this rehabilitation approach has been utilized with some success in various clinical populations, such as stroke and spinal cord injury, and is believed to target neuroplasticity. Specific to persons with MS, body weight supported treadmill training has shown great promise in improving quality of life, symptoms and functional mobility in two small (n=4 and n=6) pilot investigations. However, previous research has been hampered by methodological limitations including small sample size, lack of a control group and limited training sessions. Consequently, no firm conclusion regarding the benefit of body weighted supported treadmill training in persons with MS can be drawn. The proposed project seeks to determine if twenty-weeks of body weight supported treadmill training leads to improvements in physiological function, mobility and quality of life in persons with MS with severe mobility limitations. The outcomes of this project have the potential to lead to new rehabilitation approaches capable of improving function and quality of life in persons with advanced MS.

Eligibility criteria: Inclusion Criteria:

* The criteria for inclusion are physician confirmed MS diagnosis, relapse free in the last 30 days, ability to voluntarily contract either quadriceps (e.g. extend their knee), willingness to complete 20 week intervention, and physician approval to engage in manual BWSTT. The diagnosis of MS based on either Poser's or McDonald's criteria and its type based on Lublin and Reingold criteria will be confirmed by the patient's neurologist using a standard form letter.

Exclusion Criteria:

* The criteria for exclusion are having a relapse in the last 30 days, inability to contract the quadriceps, and unwilling to complete the 20 week intervention.

Primary outcomes:
measure: Clinical Disability
timeFrame: 5 months
measure: Quality of Life
timeFrame: 5 months
Secondary outcomes:
measure: Walking function
timeFrame: 5 months
measure: Balance
timeFrame: 5 months
measure: Cardiorespiratory fitness
timeFrame: 5 months
Other outcomes:
Locations:
city: Urbana-Champaign
country: United States
facility: University of Illinois UC
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Jacob Sosnoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: