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.: PACTR202207579387579 Date of Approval: 22/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF BLOOD FLOW RESTRICTION AND PROPRIOCEPTION TRAINING IN RECURRENT ANKLE SPRAIN PATIENTS
Official scientific title EFFECT OF BLOOD FLOW RESTRICTION AND PROPRIOCEPTION TRAINING IN RECURRENT ANKLE SPRAIN PATIENTS
Brief summary describing the background and objectives of the trial Ankle sprains are among the most common recurrent injuries of the lower extremity. More than 75% of reported ankle sprains occur on the lateral ankle, whereas the remaining 25% of ankle sprains comprise injury to medial and high ankle sprains The purposes of this study will be: (1) To investigate the effect of combining blood flow restriction and proprioception training on stability index, and limits of stability of balance in recurrent ankle sprain patients. (2) To investigate the effect of combining blood flow restriction and proprioception training on peak torque of dorsiflexors, planter flexors, evertors, and invertors in recurrent ankle sprain patients. (3) To investigate the effect of combining blood flow restriction and proprioception training on active and passive joint position sense in dorsi and planter flexion directions in recurrent ankle sprain patients. (4) To investigate the effect of combining blood flow restriction and proprioception training on physical function in recurrent ankle sprain patients. (5) To investigate the effect of combining blood flow restriction and proprioception training on preventing reinjury after 3 months of rehabilitation in recurrent ankle sprain patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/08/2022
Actual trial start date
Anticipated date of last follow up 29/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Strengthening exercises and Bracing four weeks Muscle strengthening exercises for 4 directions of ankle movement each movement (dorsiflexion, planter flexion, inversion, and eversion) and bracing 17 Active-Treatment of Control Group
Experimental Group blood flow restriction training with conventional therapy four weeks of rehabilitation four weeks of rehabilitation blood flow restriction combined with Conventional therapy 17
Experimental Group proprioception training with conventional therapy 4 weeks proprioception training with conventional therapy 17
Experimental Group blood flow restriction with proprioception training and conventional therapy 4 weeks blood flow restriction, proprioception training, and conventional therapy 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The patient's age between 20 and 30 years old (Jacob et al., 2019). ❖ Participants will be selected from both sexes. 24 ❖ Participants BMI will be between 18 and 24.9 (Kg/m²) (Eamonn et al., 2019). ❖ Dominant or non-dominant lower limb (Shakti et al., 2015). ❖ Grade I, and II recurrent ankle sprain patients (Rasika et al., 2016). ❖ Participants self-reported a history of at least one significant lateral ankle sprain (LAS) greater than 12 months prior to testing, and recurring ankle sprains, ankle “giving way,” and/or “feelings of instability.” (Jacob et al., 2019). ❖ Participant will have unilateral recurrent ankle sprain (Saeed et al., 2020). A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity (Jacob et al., 2019). ❖ A history of a fracture in either limb of the lower extremity requiring realignment (Jacob et al., 2019). ❖ Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in interruption of desired physical activity (Philip et al., 2014). ❖ Hip joint or, Knee joint replacement (Emily et al., 2018). ❖ Patients possibly at risk of adverse reactions of blood flow restriction are those with poor circulatory system, obesity, diabetes, arterial calcification, sickle cell trait, severe hypertension, or renal compromise (Jacob et al., 2019). 25 ❖ Any neurological conditions which affect proprioception such as polyneuropathy, multiple sclerosis, and sensory ataxia (Helena et al., 2015). ❖ Vestibular deficits, and vision problems (Helena et al., 2015). ❖ Pregnancy. Adult: 19 Year-44 Year 20 Year(s) 30 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 07/11/2021 faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street Giza Giza 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome muscle strength. before and after intervention
Primary Outcome active and passive joint position sense. before and after intervention
Secondary Outcome Balance before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 ahmed elzyat street Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahmoud Gaber Nagdi 20 ahmed Ismail street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 ahmed elzyat street Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Gaber Nagdi mahmoud.gaber@hu.edu.eg 01003551495 28 ahmed Ismail street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of physical therapy Heliopolis university.
Role Name Email Phone Street address
Public Enquiries Rania Refaat Ali Ahmed roni_diamond@yahoo.com 01001593155 22 elnozha elgededa
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Wadida Hasan Abd El Kader dr.wadida.hassn@Gmail.com 01001097571 20 bein srayat street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information