Exploratory study to develop hypotheses
ID
Bron
Verkorte titel
Aandoening
equinovarus foot
stroke
foot and ankle kinematics
soft tissue surgery
Ondersteuning
Roessingh Research and Development
Roessinghsbleekweg 33 b
7522 AH Enschede
The Netherlands
Roessinghsbleekweg 33 b
7522 AH Enschede
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Lower extremity body motion (kinematics) during gait
Achtergrond van het onderzoek
Rationale: Equinovarus is the most frequently seen foot deformity in the affected leg after stroke and compromises the patient’s walking ability and participation in daily life. Surgical intervention is a promising therapy since it enables the patient to walk more independently, barefoot, without the need of an orthosis. However, the effects of the foot and ankle surgery on restoring foot and ankle kinematics and kinetics, walking ability and on quality of life are not or not extensively studied.
Objective: The aims of this study are to explore the effects of foot and ankle surgery on the equinovarus foot deformity of patients after stroke in terms of foot function, walking abilities and social participation.
Study design: This study has an exploratory design with two measurement sessions: one 2 months before and the other 6 months after foot and ankle surgery.
Study population: Twenty adult stroke survivors who are patients at the Roessingh Rehabilitation Centre, with chronic hemiplegia and walking disabilities due to an equinovarus foot deformity will participate. These stroke patients are selected clinically to undergo equinovarus surgery and are subsequently asked to participate in this study by their rehabilitation physician.
Intervention: The intervention consists of standard techniques applied in soft-tissue surgery of equinovarus foot deformities.
Main study parameters/endpoints: The main study parameters includes the effect of surgery on restoring foot and ankle kinematics (motion). Furthermore, the effects of surgery on walking ability such as walking speed and endurance and fall risk, as well as daily participation measures is assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks for the subjects are limited, since the tasks represent functional and familiar movements and are performed within a safe environment. When fatigue occurs, the subjects are able to rest till recovered. Furthermore, a therapist may walk along with the subject in cases necessary or requested. In addition, most measurements used in this study are non-invasive and involve no risks to the subjects in any way. The only invasive measure is performed according to standard clinical procedures.
Participation of a subject in this experiment has no direct benefit for him/her, other than expanding knowledge about the effects of foot and ankle equinovarus surgery on restoring foot and ankle function and walking ability.
Doel van het onderzoek
Exploratory study to develop hypotheses
Onderzoeksopzet
Two measurement points:
1. One-two months before foot and ankle equinovarus soft tissue surgery
2. 6 months after surgery
Onderzoeksproduct en/of interventie
The measurements will take place befor and after standard soft-tissue surgery
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Unilateral ischaemic or haemorrhagic hemiparetic stroke
2. Time since stroke > 6 months
3. Age 18 years or older
4. Walking disabilities and/or fall incidents and/or pressure sores on the foot and/or unable to walk bare foot due to structural or dynamic equinovarus foot deformity, including
a. problems with stability in stance
b. problems with foot clearance during swing
c. problems with foot prepositioning in early stance
5. Subject is able to participate in an 1.5 hour session, including several stand and walking activities (walking aids allowed) with breaks in-between
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Complicating medical history such as cardiac, pulmonary, neurological or orthopaedic disorders that could affect performance of the included measurements
2. Neurolysis (fenol/alcohol) < 8 months
3. Motorpoint blockage (btx) < 5 months
4. Suffering from severe neglect
5. Severe comprehensive aphasia
6. Severe cognitive disorders
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5809 |
NTR-old | NTR5964 |
Ander register | CCMO dossier number : ABR 58628 |