Stretching and Strength Training for Improved Gait Function in Children With Spastic Cerebral Palsy
Condition: Cerebral Palsy, Spastic, Diplegic
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this randomized and controlled intervention study is to explore the effect of
      a physiotherapy intervention targeting contract and spastic hamstring muscles in children
      having bilateral spastic cerebral palsy (CP), GMFCS I-III: A stretching routine targeting
      hamstrings (and psoas if short), and a progressive strengthening program on the muscles
      extending then lower extremities (quadriceps, gluteus maximus and triceps surae)

      Study hypothesis: Stretching of hamstrings and strength training of the extending muscles in
      the lower extremities in children with bilateral spastic cerebral palsy will increase
      popliteal angle, active knee extension, and gait function.
    

Detailed description: 
      The key intervention: 16 weeks with three treatment sessions each week. Minimum pause between
      two treatment sessions is one day. Week 1 and 2: To assure the correct dosage in each
      exercise and a satisfactory education of the session done at home, all three sessions will be
      implemented with the physiotherapist the first two weeks. From week 3: Two treatment/training
      sessions with the physiotherapist and one shorter training session at home.

      Maintenance intervention: From week 17 to week nr 32.; One session pr. week will be performed
      at home, together with an assistant in school or with the physiotherapist. How this is
      accomplished will depend on what is feasible for the child and the parents.

      The physiotherapy sessions: 2 sessions pr week. 5-10 min. warm up on a treadmill or a bike. A
      stretching exercise on the hamstrings (and psoas if shortened; ≤ 5º hip extension) and 3
      strength exercises targeting the muscles extending the hip, knee and ankle.

      The intervention is expected to last 30 min. and it is an extra session on top of the usual
      physiotherapy intervention given the child.

      Home session: One session pr. week, lasting 10-15 min. No need of warm up. The session is
      contending one stretching exercise on hamstrings and one strength exercise. The exercises
      will be modified individually so the children are able to do them at home.

      Exercise registration: The physiotherapist will be asked to register the sessions performed
      each week. The reason why a session is not performed should be registered (a scheme is
      attached).

      The stretching (exercise schema p.3): Two stretching exercises will be performed on
      hamstrings, and if the psoas muscle is short (≤ 5º hip extension) there should also be a
      stretch performed on psoas. The stretching shall not be painful for the child.

      The strength training exercises (exercises schema p.4 and 5): The strength training will be
      performed following the principles of "Progressive Resistance Exercise" (PRE) and the
      recommendations from The National Strength and Conditioning Association (NSCA) concerning
      strength training for children12. The recommended weight resistance for children who are
      familiar with strength training are 60-80% of 1RM (Repetition Maximum = maximum weight when
      lifting one repetition), 2- 3 sets and 8-12 repetitions, 2 -3 times per week. Verscuhen and
      collegues13 recommendations concerning a strength training protocol for children with CP are
      taken into account: not only multi -joint exercises, but also singe - joint exercises,
      extended rest between exercises (min 2-3 minute), minimum 12 weeks of intervention and the
      children should be over 7 years of age. The standing exercises shall be performed with a back
      pack (everyone in the intervention group will get one) which is possible to load with
      weights/bottles of water.

      Customization of weight resistance

      Children having CP are likely to be diverse and according to physical conditions and because
      of that 1 Repetition Maximum (1RM) will most likely be to difficult to perform. For
      estimation of the optimal and individualized resistance throughout the period of intervention
      a modified test shall be performed.

      The test will be performed after the child have understood and completed the exercises
      correct, during the first two weeks. Until that the physiotherapist will do a mapping of the
      child's strength skills in order to recognize the wright amount of weight for the child for
      12 repetitions and 2 series. As of week 3 there are 3 series per exercises. Recommendations
      from the study done by Sholtes et all14 are used for guiding of optimal weight dosage. In
      this study they found that for 8 RM in a sit- to stand exercise, for those having CP GMFCS
      I-III the weight should be 35%, 30% and 25% respectively of body weight.

      Performance of the RM test: Starting out with 3 repetitions without any resistance throughout
      the range of moment. Every repetition shall be performed as correct and controlled as
      passible throughout the range of moment and the speed is 2-3 sec. per extension/flexion
      movement. If one repetition is carried out incorrectly with respect to speed and movement
      quality it shall not be counted.

      The RM test shall be conducted the first time in the end of the second week (12 RM x 3
      series), then next time in week 5. (10 RM x 3 series), week 8. (8 RM x 3 series), and finally
      in week 14. (8 RM x 3 series). When the child can do more than 12, 10 or 8 repetitions
      respectively, there shall be added more weight. The weight changes shall be registered in a
      registration form.

      RM test shall be performed in exercise nr 1),2) and 3). Exercise nr 4) is mostly an awareness
      exercise where the focus is on quality and the ability to activate m.vastus medialis by doing
      a max extension in the knee in a prone position.
    

Intervention name(s): Stretching and progressive strength training
Intervention type(s): Other
Intervention description(s): Intervention implemented by local physiotherapist.16 weeks, three treatment sessions each week. Minimum pause between two treatment sessions is one day. Week 1 and 2: To assure the correct dosage in each exercise and a satisfactory education of the session done at home, all three sessions will be implemented with the physiotherapist the first two weeks. From week 3: Two treatment/training sessions with the physiotherapist and one shorter training session at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment