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Distal Radius FractureNCT02494011

Closed Kinetic Chain Exercise Versus Russian Current Stimulation in Rehabilitation of Colles' Fracture.

A study testing traditional exercise, Russian current stimulation and closed kinetic chain exercise in people with Distal Radius Fracture, run by October 6 University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compared the effects of closed kinetic chain exercise and Russian current stimulation on pain, functional disability, wrist range of motion (ROM) and grip strength in patients with colles' fracture. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Distal Radius Fracture
What is being tested?
traditional exercise, Russian current stimulation and closed kinetic chain exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Jan 2014to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients with stable colles' fractures treated conservatively with closed reduction

Who cannot join

  • Patient less than 20 years old.
  • Intraarticular fracture of involved hand.
  • Any problem affects shoulder /elbow joints of the involved side.
  • Nerve lesions.
  • Fracture of the ulna.

About this study

This study compared the effects of closed kinetic chain exercise and Russian current stimulation on pain, functional disability, wrist range of motion (ROM) and grip strength in patients with colles' fracture. Forty five patients with stable colles' fractures are randomly classified into three groups with fifteen patients in each group; Group I received traditional exercise in the form of; Mobilization, stretching exercises, range of motion exercises (passive and active) and edema control of the wrist joint. Group II stimulated by electrical Russian current in addition to traditional exercise. Group III received closed kinetic chain exercise (wall press, plyometric wall push up, Quadruped rhythmic stabilization, and Push up exercises) plus traditional exercise. All outcome measures including Pain, function, Wrist ROM, and grip strength were evaluated before and after the treatment program.

Read the detailed description

Material and Methods Patients Forty five patients with stable colles' fractures collected from October 6 hospital and elsahel hospital and treated conservatively with closed reduction and casting and after removal of plaster cast they involved in the study from January 2013 to May 2013. All patients were assigned randomly into three groups by drawing of lots; group I (traditional exercise), group II (Russian stimulation) and group III (CKC).

Exclusion criteria were:

  1. Patient less than 20 years old.
  2. Intraarticular fracture of involved hand.
  3. Any problem affects shoulder /elbow joints of the involved side.
  4. Nerve lesions.
  5. Fracture of ulna.

Intervention

Group I received traditional exercise program in the form of;

  1. Mobilization: With patient sitting on high back support chair, gentle traction with oscillatory technique (gliding) for thirty seconds were used to increase wrist range of motion in all directions with the frequency of two strokes per one second and repeated six times during session. For progression ten seconds was added to the frequency of mobilization technique each session.
  2. Stretching exercises: Wrist flexors (flexor carpi radialis and flexor carpi ulnaris), extensors (extensor carpi radialis longus and brevis and extensor carpi ulnaris), radial deviators and ulnar deviators were stretched gently within the limit of pain with fifteen to twenty seconds hold at end of creeping movement of contractile and noncontractile elements (muscles and tendons). Stretching exercise for all muscles was repeated ten times during session.
  3. Passive range of motion: The wrist and fingers were moved slowly, gently and smoothly in all directions passively through the available range of motion. Passive range of motion was applied for five minutes at beginning and for five minutes at the end of session.
  4. Active range of motion: Patient was asked to perform wrist flexion, extension, radial and ulnar deviation as well as fingers flexion, extension and abduction actively as much as possible for two sets each set ten repetitions (i.e. twenty repetitions at beginning of session and twenty repetitions at end of session).
  5. Edema control: hand was elevated on towel with pressure applied to the volar and dorsum of the hand with passive ROM applied by the examiner firstly then patients was asked to perform flexion and extension of fingers for fifteen repetitions of fifteen second relax for three times.

Group II received Russian current stimulation in addition to traditional exercise:

Electrical stimulation was carried out using phyaction 787 device (Manufactured by Uniphy, serial number 24823, Netherlands). Two equal sized carbon rubber electrodes were placed on common flexor origin (below medial epicondyle of humerus) and the other on distal part of flexor carpi radialis and flexor carpi ulnaris, perpendicular to the longitudinal axis of the forearm for fifteen minutes time of stimulation. The frequency was 2.5 kHz, with a burst duty cycle of 50% and intensity adjusted according to patient tolerant. The burst duration is 10 milliseconds at 50 Hz.

Group III received closed kinetic chain exercise plus traditional exercise:

  1. Wall press exercise: The patient stood with feet shoulder-width apart, arms held directly out in front of the body at 90º of elevation against the wall. Feet are approximately two to three feet (0.6-0.9 meter) away from the wall. The patient pressed on the wall with the distal extremity fixed on stable surface and asked to keep pressing for thirty seconds.
  2. Plyometric wall push-up exercise: The patient stood away from the wall by about two feet with both arms in front of body at approximately 90o. The chest was lowered toward the wall until the elbows were bent approximately 45º to 60º. The patient then forcefully pushed the wall to return to starting position.
  3. Quadruped rhythmic stabilization exercise: Patient on hands and knees on a table or floor with the head and spine kept in neutral position. The examiner instruct the patient to hold the body without any movement. Against short, rapid pushing motions from side to side, front to back, and along diagonals. The pushing motions progressed from submaximal to maximal intensities and from slow to fast. The patient was asked to preserve the balance while the exercise maintained for thirty seconds, and each week the time increased by five seconds for progression.
  4. Push up exercise: Quadruped on a plinth or on the floor. The patient lowered the body into arms until the elbows bent approximately 45º to 60º. The patient then pushed the floor to return to the starting position.

All patients in the three groups were applied the program 3 timed a weak.

CKC exercises performed ten times and each week two more repetitions added as a progression.

The aim of this study was explained and informed consent was obtained from all patients.

Outcome Measures Pain, functional disability, ROM measurements (wrist flexion-extension, radial-ulnar deviation), and grip strength of injured hand were used as outcome measures. Pre-treatment (baseline) and post- treatment (after six weeks) measurements were recorded.

Pain and functional disability Patient rated wrist evaluation (PRWE) questionnaire: The PRWE questionnaire considered a subjective outcome measure consisting of fifteen questions answered on a scale of one to ten. Five questions focus on wrist pain, and ten questions focus on function. The patient was asked to describe the pain as well as the function of the involved hand on the scale and the answered numbers for pain and function were calculated for each one separately for analysis.

Range of Motion Baseline digital goniometer (Baseline ®, Aurora, IL, USA) for assessment of wrist ROM; flexion, extension [14], radial and ulnar deviation [15]. The device displays 0 to 180 degrees on an LCD screen for viewing readings, and has the ability to freeze angle measurements for reference. The goniometer has a durable powder-coated steel or plastic exterior with inch/cm marks screened on its arms.

Grip Strength A Jamar dynamometer for measurement of grip strength in kilograms (Jamar, J.A. Preston Co., Michigan, USA) [16,17]. The maximal muscle strength was measured with elbow flexion 90°, and wrist placed in neutral position [18].

Range of motion and grip strength performed for 3 repetitions and the mean of the three trials was record.

Being tested
traditional exercise, Russian current stimulation, closed kinetic chain exercise
Keywords
Colles' Fracture; CKCE; Russian current
Medical subject headings
Wrist Fractures, Colles' Fracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • traditional exerciseOther

    Also called I

    mobilization stretching exercise

  • Russian current stimulationOther

    Also called II

    stimulation to wrist flexors for 15 minutes

  • closed kinetic chain exerciseOther

    Also called III

    wall press exercise plyometric exercise

Study groups in NCT02494011
Study groupRoleWhat they receive
traditional exercise (group I)ExperimentalMobilization:2 strokes per one second and repeated 6 times during session * stretching exercise: 15 to 20 minutes * passive range of motion: 5 minutes at beginning and at end * active range of motion: 20 repetition * oedema control: 15s active contraction of fingers of 15s relax for 3 times
Receives: Other: traditional exercise
russian current stimulation (group II)ExperimentalThe frequency was 2.5 kHz for 15 minutes
Receives: Other: traditional exercise; Other: Russian current stimulation
CKC (group III)Experimentalwall press exercise - plyometric exercise-Quadruped rhythmic stabilization- press up exercise closed kinetic chain exercises performed 10 times and each week 2 more repetitions added as a progression
Receives: Other: traditional exercise; Other: closed kinetic chain exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient rated wrist evaluation (PRWE) questionnaire

    Measured: 6 weeks

Secondary outcomes (1)
  1. Baseline digital goniometer (Baseline ®, Aurora, IL, USA) for assessment of wrist ROM

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494011
Sponsor's protocol ID
00300
Status last verified
Aug 2015
First submitted
4 Jul 2015
Last updated
4 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Belloti JC, Santos JB, Atallah AN, Albertoni WM, Faloppa F. Fractures of the distal radius (Colles' fracture). Sao Paulo Med J. 2007 May 3;125(3):132-8. doi: 10.1590/s1516-31802007000300002.

    PubMed 17923936

Questions about this trial

What is this clinical trial studying?

A study testing traditional exercise, Russian current stimulation and closed kinetic chain exercise in people with Distal Radius Fracture, run by October 6 University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient rated wrist evaluation (PRWE) questionnaire (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02494011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2015.

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