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Determine the effect of an upper leg muscle surgery on stroke survivors walking with a stiff knee gait.


- candidate number21900
- NTR NumberNTR5129
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-apr-2015
- Secondary IDsNL51373.044.14 Medisch Ethische Toetsingscommissie Twente (METC)
- Public TitleDetermine the effect of an upper leg muscle surgery on stroke survivors walking with a stiff knee gait.
- Scientific TitleDetermine the effect of rectus femoris transfer on stroke survivors walking with a stiff knee gait on functional-, activity- and participation level.
- ACRONYM
- hypothesisFalling and tripping are due to foot clearence problems in stroke patients who have a Stiff Knee Gait (SKG). SKG is defined as diminished and delayed peak knee flexion in swing. One main cause of stiff-knee gait in stroke patients is spasticity in the rectus femoris muscle. A treatment to increase diminished knee flexion in SKG is a rectus femoris transfer (RFT). This surgery (RFT) is often applied in cerebral palsy children and stroke patients, the m. rectus femoris will be fixed from ventral side of the knee (extensor) to dorsal side of the knee (flexor). Therefore, the m. rectus femoris function will switch from a knee flexor to a knee extensor. RFT intervention is limited review with subjective measurements in stroke patients.
- Healt Condition(s) or Problem(s) studiedIschemic stroke, Stiff knee gait
- Inclusion criteria- Patient has eligible for a rectus femoris transfer surgery by treating physiatrist/orthopedist and has been informed about the surgery.
- Age > 18 years
- More than 6 months after stroke
- Patient walks independently (FAC ≥3)
- Patient knows time, place and person. Patient could understand motor-,cognitive and communicative instructions.
- Exclusion criteria- Neurological impairments that are not due to stroke
- Progressive disease that influence gait
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2015
- planned closingdate31-dec-2021
- Target number of participants17
- InterventionsInapplicable.
- Primary outcomePrimary study outcome is knee flexion in swing phase
- Secondary outcomeSecundary study outcomes are hip , knee ankle kinematics. EMG actvity of muscles of the under extremity, BORG- and VAS questionnaires on tonus, Duncan-Ely test for m. rectus femoris, six minutes walking test, pulmonary-function test, Timed Up and Go (TUG), L-test, Timed Up Stairs test, Motricity Index, Rivermead Mobility Index en the Stroke Impact scale (SIS).
- TimepointsA pre and posttest design will be used.
Primary outcome will be measured by:
Vicon 3D gait analysis

Secondary outcomes will be measured by:
Electromyography
CosMed K4b2
Borg en VAS questionnaires
Duncan-Ely test
Force platform
Motricity Index
Rivermead Mobility Index
6 minutes walking test
Timed Up and Go-test
Timed Up Stairs test
L-Test
10 meter looptest
Stroke Impact Scale8
- Trial web siteInapplicable.
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Tenniglo
- CONTACT for SCIENTIFIC QUERIES J.H. Buurke
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Roessingh Research & Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-apr-2015 - 26-apr-2015


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