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Do Imagined Movements Improve Dexterity in Distal Radius Fractures?

1 mai 2018 mis à jour par: Thomas Hughes, University of Derby

Does an Imagined Movement Regime Improve Dexterity Following Conservatively Managed Distal Radius Fractures in Older Adults? A Pilot Randomised Controlled Trial

A distal radius fracture is a break at the wrist end of the long bone on the outside of the forearm. It is common, and can cause problems with stiffness, pain and use of the hand and arm for several months. This study is investigating whether imagined movements whilst in the plaster improve dexterity, reduce pain or improve movement when the plaster is removed. As this is a pilot study the aim is to test research and assessment procedure to guide further studies.

Imagined movements involve imagining the wrist moving, without actually moving the wrist. It has been suggested that immobilisation, for example in plaster, can affect the part of the brain responsible for movement and sensation. It has also been suggested that imagined movement can reduce this impact.

This study is investigating subjects over the age of 50 with relatively low impact trauma. Younger subjects and higher velocity injuries will be excluded as this introduces an unwanted variable. Likewise, any fractures requiring surgery, or subjects with pre-existing upper limb injury or deformity will be excluded.

Patients will be invited to participate following their attendance at the local Accident and Emergency department in Newport, South Wales, or the minor injuries department at Ysbyty Ystrad Fawr Hospital, Ystrad Mynach. Sampling will run for approximately 2 months and all participants will be given standard exercises. All participants will attend an appointment at approximately 1 week and be randomised into treatment or control group. The treatment group will be taught imagined movements and be asked to perform these for 10 minutes, four times a day, the control group will continue with standard exercises.

All subjects will attend again for assessment of dexterity, pain and movement after the plaster has been removed, (4-8 weeks dependent on team). This concludes the study.

Aperçu de l'étude

Statut

Complété

Intervention / Traitement

Description détaillée

At initial attendance in Accident and Emergency, subjects that meet the inclusion criteria will be offered an information sheet, and will be asked whether they want to be included in the trial. If they agree, a consent form regarding being contacted about the study and an assessment form will be completed by the advanced nurse practitioner. The forms will be given to the primary researcher and filed securely to comply with The Data Protection Act. All patients, including those who do not wish to participate or don't meet the criteria will be given the standard advice and exercise booklet. This is usual for this group of patients.

The lead researcher will contact each subject within 3 days to discuss the study, and arrange an appointment at 7-10 days to begin the study. This is necessary ethically in order to provide a 'cooling-off' period for the subjects to consider whether they wish to participate. It will also give time for radiology reports to be completed and any subjects with discounted radius fracture can be excluded.

Potential subjects attending the initial appointment at 7-10 days in the outpatient physiotherapy department will be offered the full consent form. Those that do not attend or do not consent will be referred back to Accident and Emergency and return to usual care. Those that consent will be randomised into control or intervention group using a computerised random number generator. The control group will continue with maintenance exercises. Having a control group means that the intervention (imagined movements) can be isolated and tested with greater confidence. This helps to improve the quality of the study and this benefit to the study is believed to outweigh the small risk that having a control group would raise. By having the control group follow usual care as closely as possible further minimises ethical issues and potential risks. All efforts have been made to ensure this but it is recognised that all participants will need to attend two appointments that they would not normally attend on normal care. These are necessary to provide a cooling off period and collect data for the study.

The intervention group will have the same exercises as the control group plus imagined wrist exercises. The exercises will be taught to the subject by reading through the booklet with them, this ensures the advice is standardised. As the intervention is targeting part of the brain involved in the control of movement, high frequency is considered important. The imagined movement programme, is amalgamated from two previous studies and will consist of imagined wrist movement in all planes. The frequency of 15 minutes every waking hour from one study is deemed impractical and another study suggests that 15 minutes of mental practice a day preserved range of motion. Therefore approximately 10-15 minutes, four times a day has been selected as a practical compromise and mirrors routine advice.

An appointment will be arranged as soon as is practically possible, aiming for the same day or day after removal of plaster at approximately 4-8 weeks, (varies between teams). This is to reduce the chance of movement out of plaster affecting the outcome measures.

At the 4-8 week appointment the primary outcome measures of dexterity using the Purdue peg-board, and secondary outcome measures of pain and active wrist range of motion will be measured and recorded in the outpatient physiotherapy department.

The subjects will be randomised into control or intervention group which will reduce selection bias. Only standardised objective outcome measures are being used which reduces the chances of the researcher influencing responses. As this is a small, educational study there is no funding and therefore the researcher will be randomising the participants, providing the exercises, and assessing the outcome measures. It is recognised that this is a potential source of bias as the researcher is not blind to group allocation, however, as this is a pilot study this is felt to be an acceptable weakness and will be recognised in write up. It is also a valuable educational experience for the student researcher to be involved in each part of the study.

Broadly the timetable will be two months of recruitment followed by data collection which will continue for up to eight weeks after recruitment has terminated. Data analysis and interpretation will commence whilst collection is ongoing and continue for approximately two to four weeks. The final reporting and write up will follow this.

Sampling is planned to run for 2 months and all potential subjects meeting the criteria will be given the opportunity to participate. Metrics from the local departments, (after allowing for subjects not consenting or meeting the criteria), suggest this could produce a sample size of around 40. This is difficult to predict but one of the aims of this pilot study is to test these procedures. Recruitment will be initially undertaken by advanced nurse practitioners in Accident and Emergency.

Type d'étude

Interventionnel

Inscription (Réel)

4

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Gwent
      • Newport, Gwent, Royaume-Uni, NP20 2UB
        • Aneurin Bevan University Health Board

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Aged 50 and over
  • Closed distal radius fracture
  • Lives within Aneurin Bevan University Health Board geographically

Exclusion Criteria:

  • Aged under 50
  • Lives outside Aneurin Bevan University Health Board geographically, or unable to attend appointments
  • Open distal radius fracture
  • Requires surgery to distal radius fracture
  • Fracture is subsequently ruled out
  • Any additional upper limb injury
  • Bilateral wrist fracture
  • Unable to give consent
  • Unable to follow instructions or speak English
  • Pre-existing wrist injury, deformity or neurological impairment of either upper limb
  • Subject describes significant emotional and/or psychological trauma at the time of injury

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention
Group follows usual care plus imagined movements in a home exercise plan. The exercises will be taught to the subject by reading through an exercise booklet with them, this ensures the advice is standardised. The imagined movement programme will consist of imagined wrist movement in all planes. The frequency of approximately 10-15 minutes, four times a day has been selected as a practical compromise of previous investigations, (Moseley, 2004 and Frenkel et al., 2014), and mirrors routine advice.
Imagined wrist movements, 10-15 minutes, 4 times a day.
Autres noms:
  • Imagerie motrice
Aucune intervention: control
Follows usual care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dexterity
Délai: 4-6 weeks
Time in seconds using standardised Purdue peg-board
4-6 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain
Délai: 4-6 weeks
Visual analogue scale for pain (x/10)
4-6 weeks
Active range of motion of the wrist
Délai: 4-6 weeks
Goniometry of wrist (degrees)
4-6 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Sue Kennedy, University of Derby

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 octobre 2017

Achèvement primaire (Réel)

1 janvier 2018

Achèvement de l'étude (Réel)

1 janvier 2018

Dates d'inscription aux études

Première soumission

6 octobre 2017

Première soumission répondant aux critères de contrôle qualité

13 octobre 2017

Première publication (Réel)

16 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • DRF2017

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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