Protocol summary
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Study aim
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Determining the effect of supervised rehabilitation on gait symmetry and regularity after acute ankle sprain
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Design
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Quasi-experimental, pretest-posttest, single-group, non-randomized clinical trial, with a healthy reference group without intervention for comparison with normative values. On 16 patients, unblinded.
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Settings and conduct
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This study will be conducted on 16 patients with acute ankle sprain. This is a quasi-experimental clinical trial with a pre-post design; therefore, randomization or blinding is not possible in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients aged between 18 and 50 years,
Patients with Grade 1 or 2 ankle sprain,
Patients with an acute ankle sprain, meaning the injury occurred between 7 days and 1 month ago,
Presence of symptoms such as swelling or pain on the lateral side of the ankle, limited ankle range of motion, and tenderness over the lateral ligaments,
Minimum literacy level, with the ability to read and write at least at a middle school level
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Intervention groups
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The intervention group will receive 10 supervised ankle rehabilitation sessions. Each intervention session, which includes electrotherapy and therapeutic exercises, will last between 1.5 to 2 hours. Overall, the therapeutic exercises will include strengthening, neuromuscular, range of motion, and balance exercises.
The duration of electrotherapy in each session will be between 15 to 30 minutes, using TENS (Transcutaneous Electrical Nerve Stimulation). Strengthening exercises for the muscles around the ankle will be performed using resistance bands of varying levels. Balance and proprioception exercises will be conducted using a balance board and other related equipment.
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Main outcome variables
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step regularity; stride regularity; gait symmetry
General information
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Reason for update
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The inclusion age range was updated from 18–50 years to 18–55 years, as patients older than 50 years who met all other inclusion criteria (physician-diagnosed Grade I or II acute lateral ankle sprain) presented during the data collection period. In addition, the achieved sample size is being recorded as 15 participants per group (patient and healthy reference groups), reflecting attrition during study conduct.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250503065584N1
Registration date:
2025-08-07, 1404/05/16
Registration timing:
prospective
Last update:
2026-08-22, 1405/05/31
Update count:
2
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Registration date
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2025-08-07, 1404/05/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-08-22, 1404/05/31
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Expected recruitment end date
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2025-11-21, 1404/08/30
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Actual recruitment start date
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2025-08-11, 1404/05/20
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Actual recruitment end date
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2026-01-20, 1404/10/30
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Trial completion date
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2026-01-20, 1404/10/30
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Scientific title
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Investigating the effect of supervised rehabilitation on gait symmetry and regularity after acute ankle sprain
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Public title
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The effect of rehabilitation on gait symmetry and regularity
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients aged between 18 and 55 years
Patients with Grade 1 or 2 ankle sprain
Patients with an acute ankle sprain, meaning the injury occurred between 7 days and 1 month ago
Presence of symptoms such as swelling or pain on the lateral side of the ankle, limited ankle range of motion, and tenderness over the lateral ligaments
Minimum literacy level, with the ability to read and write at least at a middle school level
Exclusion criteria:
Patients with syndesmotic injury in addition to the ankle sprain.
Patients with a history of surgery or fracture in the lower limbs within the past year.
Patients who had sustained an acute injury to the musculoskeletal structures of other lower limb joints within the past three months that affected joint integrity and function—such as a sprain or fracture—and had missed at least one day of their usual physical activity.
Patients with neurological disorders such as stroke, multiple sclerosis (MS), or neuropathy.
Individuals who had experienced an ankle sprain within the past 12 months.
In the treatment of ankle sprains, initial protection is typically provided for one to two weeks, followed by the use of bandages or tape, which does not interfere with our study. However, patients using foot or ankle orthoses were excluded from the study.
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
32
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-05-14, 1404/02/24
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Ethics committee reference number
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IR.IUMS.REC.1404.159
Health conditions studied
1
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Description of health condition studied
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Acute ankle sprain
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ICD-10 code
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S93.4
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ICD-10 code description
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Sprain of ankle
Primary outcomes
1
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Description
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Step regularity based on trunk acceleration
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Timepoint
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Before the intervention and immediately after the tenth session of supervised ankle rehabilitation.
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Method of measurement
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The Phyphox software installed on the mobile phone
2
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Description
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Stride regularity based on trunk acceleration
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Timepoint
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Before the intervention and immediately after the tenth session of supervised ankle rehabilitation.
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Method of measurement
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The Phyphox software installed on the mobile phone
3
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Description
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Gait symmetry based on trunk acceleration
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Timepoint
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Before the intervention and immediately after the tenth session of supervised ankle rehabilitation.
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Method of measurement
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The Phyphox software installed on the mobile phone
Intervention groups
1
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Description
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Intervention Group:In this study, the intervention consists of supervised ankle rehabilitation. Supervised ankle rehabilitation refers to the use of electrotherapy and exercise therapy based on current guidelines. The rehabilitation program will be conducted over 10 sessions (approximately 3 sessions per week). The duration of electrotherapy in each session will range from 15 to 30 minutes (using TENS current). Each intervention session, which includes both electrotherapy and exercise therapy, will last between 1.5 to 2 hours.In general, the exercise therapy includes strengthening, neuromuscular, range of motion, and balance exercises. Strengthening exercises for the muscles surrounding the ankle will be performed using resistance bands of varying levels. Balance and proprioception training will be carried out using a balance board and other equipment.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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We do not have ethical approval for this purpose.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available