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Stretching and Strength Training for Improved Gait Function in Children With Spastic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02917330
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Merete Aarsland Fosdahl, Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic, Diplegic Other: Stretching and progressive strength training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stretching and Strength Training for Children With Cerebral Palsy -an Intervention Study
Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strength and stretching intervention
Treatment as usual + a strength and stretching intervention together with a physiotherapist
Other: Stretching and progressive strength training
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.

No Intervention: Control group
Treatment as usual



Primary Outcome Measures :
  1. Change in Hamstrings length/popliteal angle (R1 in MTS) [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]

    The tests are conducted with the child lying supine on a bench in a silent examination room and the measurements are done using a plastic goniometer, commonly used for joint and muscle measurements in the clinic.

    Two testers are doing the tests and they are a test team. If there is a contracture in the hip a pillow is placed under the knee to keep the lumbar spine straight. One tester is performing the stretch on hamstrings and the other tester is reading of the degrees on the goniometer. The pivot point for the flexion/extension axis in the knee is over the lateral condyle of femur. The aiming point for the longitudinal axis in femur is trochanter major and the aiming point for the longitudinal axis in tibia is the medial malleolus. The stationary arm on the goniometer is placed over femurs longitudinal axis and the moving arm is placed along with tibias longitudinal axis.The test is done three times and an average is calculated.



Secondary Outcome Measures :
  1. Change in Active popliteal angle [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]
    This measures quadriceps ability to extend the knee into the last range of motion. It is performed in the same position as the two tests above. The child is told to stretch out the leg as much as he or she is able to (hip is hold in 90 deg by the tester). The other tester is holding the goniometer as described above and is registering the range of motion. The test is done three times and an average is calculated.

  2. Change in Hamstrings catch (R2 modified Tardieu Scale (MTS)) [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]
    The tester is holding the actual leg, flexing the hip to 90 deg. The knee is extended and flexed slowly for two repetitions to make the child as calm and relaxed as possible, and the knee is extended fast. The quick and fast stop (catch) is measured and registered by the other tester. This test is extensively used for registration of spasticity in children with CP 18. The catch measure is only performed ones as it may change with several provocations.

  3. Changes in Three dimensional gait analysis (3DGA) [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]
    Two skilled testers are responsible for the testing. Reflecting markers are placed on the skin according to Hellen Hays full body plug-in model. One tester is placing the markers, the other is checking and it is complete when both agree on the placement. The children are instructed to walk in a self-selected gait speed across a 10 m pathway in the lab. With infra-red light, six cameras on the wall are registrating the reflex markers attached to the children's body. The child is asked to walk back and forth between to cones placed on the floor until 5 good gait cycles is registered, meaning that the child hits two force plates in the floor by left and right foot.

  4. Change in Cybex 6000, Strength test [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]
  5. Changes in Pediatric quality of life questionaire 4.0 (PedsQL) [ Time Frame: Measured at baseline, after 16 weeks and 32 weeks ]
    It is a self-reported Quality Of Life questionaire containing 23 questions, in 4 categories: Physical functioning, emotional functioning, social functioning and school functioning. The different themes gives a sum score between 0-100. Scale scores are computed as the sum of the items divided by the number of items answered. In addition to the four subscales, two summary scores can be computed: Physical Health Summary score (8 items) Psychosocial Health Summary score (15 items)



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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spastic bilateral cerebral palsy GMFCS I-III (ability to walk without aid for 10 m)
  • Popliteal angle ≥ 35°

Exclusion Criteria:

  • No surgical lengthening on hamstrings or bilateral triceps surae
  • No surgical intervention on the lower extremities one year prior to inclusion
  • No surgical intervention on the lower extremities one year prior to inclusion
  • Surgical operations which is planned for the upcoming year
  • No botulinum injections in hamstrings or other muscles in the lower extremities the last 6 month prior to inclusion.
  • External rotation in the hips ≤ 5°
  • < 90° passive ankle dorsal flexion in the ankles on a extended knee
  • Reduced ability to cooperate or receive instructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917330


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Inger Holm, Professor Oslo University Hospital, Oslo, Norway

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Responsible Party: Merete Aarsland Fosdahl, Physioteraphist, MHSc, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02917330     History of Changes
Other Study ID Numbers: 519681, 2014/1766-1
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Muscle Spasticity
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations