Prospective controlled cohort study to evaluate changes of function, activity and participation in patients with bilateral spastic cerebral palsy after Robot-enhanced repetitive treadmill therapy.

BACKGROUND: Robot-enhanced therapies are increasingly being used to improve gross motor performance in patients with cerebral palsy.

AIM: To evaluate gross motor function, activity and participation in patients with bilateral spastic cerebral palsy (BS-CP) after Robot-enhanced repetitive treadmill therapy (ROBERT) in a prospective, controlled cohort study.

METHODS: Participants trained for 30-60 min in each of 12 sessions within a three-week-period. Changes in Gross Motor Function Measure (GMFM 66) scores, standardized walking distance, self-selected and maximum walking speed (ICF domain "Activity"), and Canadian Occupational Performance Measure (COPM; "Participation") were measured. Outcome measures were assessed three weeks in advance (V1), the day before (V2) as well as the day after, and 8 weeks after ROBERT (V3 + V4).

RESULTS: 18 patients with BS-CP participated; age 11.5 (mean, range: 5.0-21.8) years, body weight 36.4 (15.0-72.0) kg. GMFCS levels I-IV were: n = 4; 5; 8; 1. There was no significant difference comparing V1 and V2. GMFM 66 (total +2.5 points, Dimension D +3.8 and E +3.2) and COPM (Performance +2.1 points, Satisfaction +1.8 points) showed statistically significant improvements for V3 or V4 compared to V1 or V2 representing clinically meaningful effect sizes. Age, GMFCS level, and repeated ROBERT blocks correlated negatively with GMFM improvement, but not with COPM improvement.

INTERPRETATION: Following ROBERT, this prospective controlled cohort study showed significant and clinically meaningful improvements of function in ICF domains of "activity" and "participation" in patients with BS-CP. Further assessment in a larger cohort is necessary to allow more specific definition of factors that influence responsiveness to ROBERT program.