Northwestern University Feinberg School of Medicine

Northwestern University Prosthetics-Orthotics Center

Pilot Study: Effect of Two Orthotic Approaches to Ankle Motion Restriction on Activity Level, Balance and Patient Satisfaction in Children with Cerebral Palsy

Co-Investigators: Stefania Fatone, PhD; Donald McGovern, CPO, FAAOP**; Theresa Clancy, PT**

Deborah Gaebler-Spira, MD, Project Director**

Petra Conaway, PT, Study Coordinator**

**Rehabilitation Institute of Chicago

Funded by: Ultraflex Systems

Status: In progress

UltraFlex AFO

Children with cerebral palsy often rely significantly on ankle foot orthoses (AFO's) for support while walking and tasks that require balance. The approach taken with orthotic management, specifically as it relates to the degree of ankle motion restriction, may impact activity level, balance, and satisfaction in children with cerebral palsy. We wish to assess the effect on activity level, balance, and patient satisfaction that the degree of ankle motion restriction provided by orthoses may have. This will be assessed by comparing complete restriction using a solid ankle foot orthosis-footwear combination (AFO-FC) versus allowing resisted, articulated motion using an Adjustable Dynamic Response AFO with supramalleolar orthosis (ADR AFO + SMO) (see picture). Both orthoses aim to improve biomechanical alignment in mid stance and restore/preserve rocker action for forward progression during walking. The AFO-FC approach accommodates limitations in muscle length within a solid AFO through alignment (choice of ankle angle). Roll-over or progression during stance is then accomplished through rockers on the shoe. The ADR AFO +SMO (with posting as needed for muscle limitations) uses variable plantar flexor and dorsiflexor resistance to influence shank biomechanics to maintain rockers for progression in stance with available motion preserved.

This study will use a single subject research design (A-A-B-C-B-C) that includes two baseline assessments one month apart wherein subjects will be assessed in their regular orthoses, followed by alternating month-long use of the two different ankle foot orthoses. Test orthoses (AFO-FC and ADR AFO + SMO) will be assigned in random order.We will recruit six children with cerebral palsy to participate in this study. Range of motion, muscle strength, muscle stiffness, spasticity, selective motor control, balance, walking function, satisfaction, and quality of life will be assessed at each time point in random order. Primary outcome measures include the Pediatric Balance Scale, the Orthotic and Prosthetic User Survey (OPUS) and Life-H. Between study visits, subjects' step activity will be monitored using a step activity monitor attached to the orthoses. To ensure that each orthosis is optimally tuned, we will use the motion analysis lab to visualize the ground reaction force vector in real time.

Related Presentations and Publications

Fatone S. (2014) Evaluating the effects of ankle-foot-orthosis footwear-combinations in children with cerebral palsy. Initiative ’93 Technische Orthopädie Symposium, March 3, Chicago, Illinois.

McGovern D, Fatone S. (2014) Evaluating the effects of ankle-foot-orthosis footwear-combinations (AFO-FCs) in children with Cerebral Palsy. Midwest Chapter of the American Academy of Orthotists and Prosthetists, One Day Fall Symposium, November 15; Hickory Hills, Illinois.

Fatone S, McGovern D, Clancy T, Conaway P, Gaebler-Spira D (2015) Effect of two orthotic approaches on activity level, balance & satisfaction in children with cerebral palsy. 41st American Academy of Orthotists and Prosthetists Annual Meeting & Scientific Symposium, February 18-21, New Orleans, Louisiana.

Foster JB (2015) More restrictive orthotic devices boost balance over time in children with CP. Lower Extremity Review, 7(2):13. http://lermagazine.com/news/in-the-moment-op/more-restrictive-orthotic-devices-boost-balance-over-time-in-children-with-cp 

Fatone S, McGovern D, Clancy T, Conaway P, Gaebler-Spira D (2015) Effect of two orthotic approaches on activity level, balance & satisfaction in children with cerebral palsy. ISPO World Congress 2015, June 22-25, Lyon, France (poster).