ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616001715460

Ethics application status

Approved

Date submitted

20/11/2016

Date registered

14/12/2016

Date last updated

14/12/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Does a hand strength exercise program improve grip strength in elderly patients with wrist fractures?

Scientific title

Does a hand strength exercise program improve grip strength in elderly patients with wrist fractures treated non-operatively? A Randomized Control Trial

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

distal radius fracture

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

intervention:

A 4 week schedule of specific hand strength exercises to perform on a daily basis at home between 2 and 6 weeks after injury

Patients will tick off a check sheet regarding adherence to the exercises and this will be collected at the 6 week mark.

The exercises to be performed in the intervention group have been discussed with the supervisor who is a hand surgeon and the physiotherapist. It will consist of 3 categories; Finger range of motion, isometric finger exercises and the use of a squeeze ball given to the patient.

The finger range of motion exercises and isometric finger exercises will be performed in the 1st week with the use of the squeeze ball to be introduced in the 2nd week and consistently used in the 3rd and 4th week.

In the intervention group, the exercises will be explained to the patient at their fracture clinic follow up on recruitment. The surgeon will explain to the participant the exercises in a 1 half hour session. Each exercise is explained to the patient clearly by the surgeon showing the patient with their own hand, and the participant then performing the exercise with their normal hand then their injured hand.

The participant will then receive a 4 week schedule to follow explaining the exercises daily and a checklist to tick off to ensure that the participant is following the exercise program.

If the participant has any questions after the visit during the 4 weeks, they are advised to contact the investigator or the surgeon for further explanation.

There is no specific duration in which the participant must complete the exercises daily. They have a set regime i.e. finger isometric exercises each finger 10 times a day in which is advised to carry out within a day, but not within a time limit of that day.

The intervention group will have a cast. The same as the control group. The short arm fibreglass cast will however have enough room to enable the participant to make a fist, and be able to touch each finger and thumb together, allowing free movement of the thenar eminence.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Control:
For all distal radius fractures managed non operatively, they are placed in a short arm full fibreglass cast at 2 weeks for a total of 4 weeks.

During this period they are asked to move their fingers however there are no specific exercises given.

Our control group will be the normal practice at our institution between 2 and 6 weeks after distal radius fracture of asking the patients to move their fingers.

Control group

Active

Outcomes

Primary outcome [1]

Grip strength will be measured using a JAMAR hand-grip dynamometer

Timepoint [1]

3 months post injury

Secondary outcome [1]

QUICK-DASH score

Timepoint [1]

3 months post injury

Secondary outcome [2]

visual analogue scale - pain

Timepoint [2]

3 months post injury

Secondary outcome [3]

Complex regional pain syndrome will be assessed using the Budapest Criteria

Timepoint [3]

3 months post injury

Eligibility

Key inclusion criteria

distal radius fracture in patients over the age of 60
single sided fracture

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

bilateral distal radius fracture
existing neurological condition which has lead to weakness in the ipsilateral limb
prior distal radius fracture in same arm
prior hand or wrist surgery in same arm
patients with dementia or unable to follow instructions

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised sequence generation in blocks

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/05/2016

Date of last participant enrolment

Anticipated

29/12/2017

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2139 - Concord

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Concord Hospital

Address [1]

Concord Hospital
Hospital Road
Concord West 2139

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Jai Sungaran

Address

Concord Hospital
Hospital Road
Concord West NSW 2139

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2015

Approval date [1]

15/03/2016

Ethics approval number [1]

CH62/6/2015-181

Summary

Brief summary

Wrist fractures are amongst the most common fractures suffered by elderly patients. 
There is limited data regarding grip strength of elderly patients who have suffered a distal radius fracture at the 2 and 6 week mark post injury.
We performed a pilot study in the last year investigating grip strength in patients with distal radius fractures at 2 and 6 weeks post injury to determine whether they could drive. One major finding was that patients over the age of 60 who suffered a distal radius fracture had around 0-5kg of grip strength when measured at 2 and 6 weeks post injury.
We also found that most patients were given a physiotherapy handout of range of motion exercises which they could perform. There was no strict guideline or recommendation of how often to perform the exercises and there were no grip strength exercises recommended. 
Grip strength in elderly patients has been noted to be a good indicator of function. Maintenance of function in the elderly patient is of great importance to a patient’s independence in mobility and activities of daily living. 
We hypothesize that a grip strength focused exercise program given to elderly patients with distal radius fractures will significantly improve patients’ grip strength and therefore function. 
This study would be of clinical significance to the elderly patient who suffers a wrist fracture. If we can improve a person’s grip strength and function, we may also improve their quality of life.

Aim/Objective: 
To determine whether an exercise program will improve grip strength in elderly patients with distal radius fractures treated nonoperatively.

Secondary objective
1. Determine whether an exercise program will improve pain in elderly patients with distal radius fractures
2. To determine whether an exercise program will improve function and reduce complex regional pain syndrome

Hypothesis
We hypothesize that adherence to a grip strength focused exercise program for a month between 2 weeks and 6 weeks post injury will improve grip strength in elderly patients who suffer a distal radius fracture.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jai Sungaran

Address

Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61 2 97675000

Fax

sungaran@optusnet.com.au

Contact person for public queries

Name

Antony Nguyen

Address

Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61 2 97675000

Fax

antony_nguyen@hotmail.com

Contact person for scientific queries

Name

Antony Nguyen

Address

Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139

Country

Australia

Phone

+61 2 97675000

Fax

antony_nguyen@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically