Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201512001195151 Date of Approval: 10/07/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Closed kinetic chain exercise versus Russian current stimulation in rehabilitation of colles¿ fracture.
Official scientific title Closed kinetic chain exercise versus Russian current stimulation in rehabilitation of colles¿ fracture.
Brief summary describing the background and objectives of the trial Objective: 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. Methods: 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. Results: Improvements of outcome measures showed that group II who received electrical Russian current stimulation has high statistical significant than Group I and Group III (p<0.05). Conclusion: The finding of the study revealed that stimulation of wrist flexors by Russian current in addition to traditional exercise program was more effective than exercise alone after colles¿ fracture.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied fracture
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 02/05/2015
Actual Last follow-up date 02/05/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised drawing of lots Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional exercise 3 times aweek 6 weeks a) Mobilization b) Stretching exercise c) Passive range of motion d) Active range of motion e) Edema control 15 Active-Treatment of Control Group
Experimental Group Russian current stimulation 3 times aweek 6 weeks stimulation of wrist flexors for 15 minutes 15
Experimental Group closed kinetic chain exercise 3 times aweek 6 weeks a) wall press exercise b)plyometric exercise c) Quadruped rhythmic stabilization exercise d) Push up exercise 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) patients with stable colles¿ fractures conservatively with closed reduction and casting 2)fracture was grade I according to frykman classification 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. 20 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/09/2012 physical therapy committee
Ethics Committee Address
Street address City Postal code Country
eldoky cairo 8763 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain and functional disability all participant were measured Pre-treatment (baseline) and post- treatment (after six weeks)
Primary Outcome Range of Motion all participant were measured Pre-treatment (baseline) and post- treatment (after six weeks)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elsahel hospital eltawheed we elnoor shoubra 5234 Egypt
october 6 university elhai elsabe october city 1234 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal funding elhai elsabe october city 9876 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor emad eldin mohamed elhai elsabe october city 9876 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
walled saber ismail elhai elsabe october city 9876 Egypt
amir saleh mohamed Giza- almokhtar street cairo 9860 Egypt
amir saleh mohamed Giza- almokhtar street cairo 9860 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator emad mohamed emad9111@live.com 01146808839 elhai elsabe
City Postal code Country Position/Affiliation
october 5 city Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries emad mohsen emad_pt@outlook.com 01028799322 elhatsa street- roxy
City Postal code Country Position/Affiliation
cairo 3785 Egypt physical therapy
Role Name Email Phone Street address
Scientific Enquiries omda ahmed emadeldin91111@outlook.com 01057490214 eldoky street
City Postal code Country Position/Affiliation
cairo 5473 Egypt physical therapy
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information