NCT03310151

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

October 6, 2017

Last Update Submit

May 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dexterity

    Time in seconds using standardised Purdue peg-board

    4-6 weeks

Secondary Outcomes (2)

  • Pain

    4-6 weeks

  • Active range of motion of the wrist

    4-6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Procedure: Imagined movements

control

NO INTERVENTION

Follows usual care

Interventions

Imagined wrist movements, 10-15 minutes, 4 times a day.

Also known as: Motor imagery
Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aneurin Bevan University Health Board

Newport, Gwent, NP20 2UB, United Kingdom

Location

Related Publications (2)

  • Frenkel MO, Herzig DS, Gebhard F, Mayer J, Becker C, Einsiedel T. Mental practice maintains range of motion despite forearm immobilization: a pilot study in healthy persons. J Rehabil Med. 2014 Mar;46(3):225-32. doi: 10.2340/16501977-1263.

    PMID: 24519331BACKGROUND
  • Moseley GL. Graded motor imagery is effective for long-standing complex regional pain syndrome: a randomised controlled trial. Pain. 2004 Mar;108(1-2):192-8. doi: 10.1016/j.pain.2004.01.006.

    PMID: 15109523BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sue Kennedy

    University of Derby

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
As this is a small, education, non-funded project masking has not been possible
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial with one control and one interventional group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Specialist Physiotherapist (MSc student)

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 16, 2017

Study Start

October 9, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations