Abstract: Preliminary Results Of A Randomized Controlled Trial Of A HIP Flexion Assist Device In MS (The 27th Annual Meeting of the CMSC and the 5th Cooperative Meeting of the CMSC-ACTRIMS)

Thursday, May 30, 2013

Francois Bethoux, MD , Neurological Institute-Mellen Center, Cleveland Clinic, Cleveland, OH

Darlene K Stough, RN MSCN CCRP , Neurological Institute-Mellen Center, Cleveland Clinic, Cleveland, OH

Michelle Harrison-Cudnik, PT , Neurological Institute-Mellen Center, Cleveland Clinic, Cleveland, OH

Diane Ivancic, CCRP , Neurological Institute-Mellen Center, Cleveland Clinic, Cleveland, OH

Matthew Sutliff, PT, MSCS , Neurological Institute-Mellen Center, Cleveland Clinic, Cleveland, OH

Susan E. Bennett, PT, DPT, EdD, NCS, MSCS , Department of Rehabilitation Science and Department of Neurology, University of Buffalo, SUNY, Buffalo, NY

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Background: hip flexor weakness contributes to decreased foot clearance and gait disturbance in MS. The Hip Flexion Assist Device (HFAD) consists of two elastic bands attached proximally to a waist belt and distally to the shoe, and enhances active hip flexion and foot clearance from the floor while walking. Results of an uncontrolled pilot study on 21 MS patients suggest that the HFAD is safe and improves walking performance.

Objectives: to evaluate the efficacy and safety of the HFAD in ambulatory MS patients with hip flexor weakness using a single blind randomized controlled design.

Methods: subjects were randomized to a treatment group (wearing the HFAD for at least 2 hours daily for 8 weeks after fitting and training) or to a control group (no intervention). Assessments were conducted at baseline (V1), 4 weeks (V2), and 8 weeks (V3). Blinded assessments, performed without the device, included walking performance (2-minute walk (2MW) and Timed 25 foot Walk (T25 FW)), lower extremity strength (hand-held dynamometer), and spasticity (Modified Ashworth Scale (MAS)). Patient-reported outcomes included the Numeric Pain Rating Scale (NPRS), Patient Determined Disease Steps Questionnaire (PDDS), MS Walking Scale 12 (MSWS-12), and a patient satisfaction questionnaire. Adverse events were recorded during study visits and weekly phone conversations. Analysis of covariance was used to compare score changes between V1 and V3.

Results: 42 subjects were randomized and 37 completed all visits (12% dropout rate) at the time of this interim analysis. There were 18 subjects in the treatment group and 24 subjects in the control group. There were no statistically significant between-group differences in subject characteristics at baseline. There was a trend favoring the treatment group on the 2MW (mean change 32.1 versus 4.7 meters, p=0.07). There was a statistically significant difference favoring the treatment group on the MSWS-12 (mean change -7.6 versus -0.44, p=0.048). There were no serious adverse events. The most common adverse event in the HFAD group was musculoskeletal pain, which occurred in 4 subjects, and improved after device use was reduced or temporarily discontinued. Over 85% of patients in the treatment group were satisfied with the HFAD at V2 and V3.

Conclusions: these preliminary results suggest that the HFAD is safe and effective in ambulatory MS patients with hip flexor weakness.

RH09 Preliminary Results Of A Randomized Controlled Trial Of A HIP Flexion Assist Device In MS