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.: PACTR201807110435545 Date of Approval: 11/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Aquatic physical therapy.
Official scientific title Feasibility and safety of an in-house aquatic therapy device
Brief summary describing the background and objectives of the trial Awareness toward benefits of aquatic therapy used either alone or adjunctive to land-based exercises may facilitate an earlier return to everyday activities and work. Aquatic therapy can be expensive, and it may be hard to achieve the advantages of different aquatic therapy devices when using only one device. Further research was warranted as a lack of studies investigating the effectiveness of operating an in-house hydrotherapy pool existed. Purpose: This study was conducted to assess the efficacy of a durable and cost-effective aquatic therapy device, to ascertain the convenience of service supplying made at least price, and to examine the overall effectiveness of aquatic in-house therapy. Reliability of this device may decrease the time and cost of the treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hip adductors strain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 08/10/2017
Actual trial start date 08/10/2017
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 01/03/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
BSUPT03/7/10/2017 Scientific ethical committee, Faculty of physical therapy, Beni-Suef University
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised In the reception of outpatient clinic, patients requested to draw sealed envelop of selection randomly for group A and group B In the reception of outpatient clinic, patients requested to draw sealed envelop of selection randomly for group A and group B Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydrotherapy 2 times/week for 2 months Half an hour/session Before commencing aquatic therapy Patients took part in one session of exercises to familiarize themselves with movements in aquatic environment 51. Each session involved 10 minutes warm-up, 20 exercises, then 10 minutes cool-down . Physiotherapy program for both groups included (45 minutes). Exercise programs designed individually based on patient examination and clinical findings as blinded 50
Control Group Hydrotherapy and ground exercises 2 times/week for 2 months Half an hour/session received hydrotherapy and ground exercises (Isometrichip adduction, active assisted then free, then the resisted) 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study included athletes with pain at the proximal insertion of the adductor muscles on palpation and resisted adduction for at least two months. All subjects read and signed an informed consent form approved by the Beni-Suef University. A pilot study conducted on five male patients with chronic adductor strain aged from 18¿38 years to estimate the intra-rater reliability for measuring outcomes. This study included participants diagnosed clinically with a chronic adductor strain. Their ages ranged from 18 to 38 years, had chronic adductor strain (grade II) for more than 3 months ago. All patients had no history of previous trauma to their legs. Only patients with gradual cessation of the offending activity are involved. Exclusion criteria involved the medical history of hemophilia, a history of metastatic disease; neuropathy of the lower extremity; an active infection (or taking medication for an infection), psychiatric disorder, pregnancy, cardiovascular disease 18 Year(s) 38 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 07/10/2017 Scientific ethical committe, faculty of physical therapy, Beni-Suef University
Ethics Committee Address
Street address City Postal code Country
Eastern Nile river bank, New Beni Suef city, Beni Suef, Egypt Beni Suef 62764 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Satisfaction 8 weeks
Primary Outcome Pain 8 weeks
Primary Outcome Muscle force 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethar Physical therapy center Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt
No Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor No Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt University
COLLABORATORS
Name Street address City Postal code Country
No Block 23, enterance 2, old police point, Elzaweya elhamra, Cairo, Egypt Cairo 11659 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Ragab dr.ibrahimragab@outlook.com +201006796917 30 Ashara street, Kesm Hadayek el kobba, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 11646 Egypt Lecturer of Orthopedic physical therapy, faculty of physical therapy, Beni Suef University
REPORTING
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