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

NCT02917330 | Completed

• 1 other identifier: 519681, 2014/1766-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic, Diplegic

Outcome Measures

Primary Outcomes (1)

• Change in Hamstrings length/popliteal angle (R1 in MTS)

  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.

  Measured at baseline, after 16 weeks and 32 weeks

Secondary Outcomes (5)

• Change in Active popliteal angle

  Measured at baseline, after 16 weeks and 32 weeks

• Change in Hamstrings catch (R2 modified Tardieu Scale (MTS))

  Measured at baseline, after 16 weeks and 32 weeks

• Changes in Three dimensional gait analysis (3DGA)

  Measured at baseline, after 16 weeks and 32 weeks

• Change in Cybex 6000, Strength test

  Measured at baseline, after 16 weeks and 32 weeks

• Changes in Pediatric quality of life questionaire 4.0 (PedsQL)

  Measured at baseline, after 16 weeks and 32 weeks

Study Arms (2)

Strength and stretching intervention

EXPERIMENTAL

Treatment as usual + a strength and stretching intervention together with a physiotherapist

Other: Stretching and progressive strength training

Control group

NO INTERVENTION

Treatment as usual

Interventions

Stretching and progressive strength training OTHER

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.

Strength and stretching intervention

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• No surgical lengthening on hamstrings or bilateral triceps surae
• Surgical operations which is planned for the upcoming year
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0027, Norway

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic

Study Officials

• Inger Holm, Professor

  Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physioteraphist, MHSc

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: September 28, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)