- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283276
Effect of Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Chronic Ankle Instability
Effect of Adding Functional Core Stability Training or Cognitive Training on Balance and Postural Control in Rehabilitation of Chronic Ankle Instability
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manar Mahmoud Mohamed, Assistant lecturer
- Phone Number: +20 100 758 7316
- Email: manarmahmoud690@gmail.com
Study Locations
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-
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Cairo, Egypt
- Recruiting
- out-patient clinic, faculty of physical therapy, Cairo university
-
Contact:
- Manar Mahmoud Mohamed, Assistant lecturer
- Phone Number: +20 100 758 7316
- Email: manarmahmoud690@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria will be based on the standard criteria outlined by the International Ankle Consortium
- History of chronic lateral ankle sprain and/or recurrent sprain and/or "feelings of instability or giving way" for 6 months or more before the study, with at least 2 episodes.
- Patients are between 18 and 30 years old. 3- Body mass index less than 30
4. The patient has a history of at least one significant ankle sprain with associated inflammatory symptoms and at least one day of interrupted physical activity.
5. Patients who have unilateral chronic ankle instability. 6. Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire (greater than 24).
Exclusion Criteria:
Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery 2- Those with low back pain that require medical or surgical intervention. 3- Having a history of an acute lower extremity injury or lower extremity surgery or fracture in the 3 months before the Study 4. Participation in formal ankle rehabilitation in the 3 months before the study.
5. Being diagnosed with neurologic dysfunction, such as multiple sclerosis, Parkinson's disease, or head injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: core stability
they will receive traditional program plus functional core stability exercise
|
Stretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions.
Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months.
The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises.
Challenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees.
The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure.
Participants shift their body weight in various directions with visual feedback on a computer screen.
Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between.
The time spent correctly tracking the target is measured and analyzed across all protocols.
Participants will receive functional core motor control (stabilization) exercise and the traditional program (consisting of stretching protocol, strengthening of all ankle muscles, and balance activities) 3 sessions per week for 2 months.
The training program consists of three phases:
|
|
Experimental: cognitive training
they will receive traditional program plus cognitive training
|
Stretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions.
Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months.
The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises.
Challenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees.
The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure.
Participants shift their body weight in various directions with visual feedback on a computer screen.
Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between.
The time spent correctly tracking the target is measured and analyzed across all protocols.
Balance training is combined with a cognitive task involving a backward digit span test, where participants must recall and repeat sequences of numbers in reverse order, testing working memory.
This test includes three difficulty levels (3-, 4-, and 5-digit sequences) performed over 35 seconds.
Participants will either recall digits while maintaining static stability or after squatting upon hearing a number, with a focus on accuracy within 5 seconds.
Performance is measured by the percentage of correctly recalled digits, and error scoring will be documented via video recording for each posture task.
|
|
Active Comparator: Core stability and cognitive training
they will receive traditional program plus functional core training plus cognitive training
|
Stretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions.
Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months.
The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises.
Challenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees.
The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure.
Participants shift their body weight in various directions with visual feedback on a computer screen.
Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between.
The time spent correctly tracking the target is measured and analyzed across all protocols.
Participants will receive functional core motor control (stabilization) exercise and the traditional program (consisting of stretching protocol, strengthening of all ankle muscles, and balance activities) 3 sessions per week for 2 months.
The training program consists of three phases:
Balance training is combined with a cognitive task involving a backward digit span test, where participants must recall and repeat sequences of numbers in reverse order, testing working memory.
This test includes three difficulty levels (3-, 4-, and 5-digit sequences) performed over 35 seconds.
Participants will either recall digits while maintaining static stability or after squatting upon hearing a number, with a focus on accuracy within 5 seconds.
Performance is measured by the percentage of correctly recalled digits, and error scoring will be documented via video recording for each posture task.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of change of pain
Time Frame: at baseline and after 2 months
|
Ankle pain will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition.
The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability.
A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
|
at baseline and after 2 months
|
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assessment of ankle instability
Time Frame: at baseline and after 2 months
|
Ankle instability will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition.
The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability.
A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium
|
at baseline and after 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of foot function
Time Frame: at baseline and after 2 months
|
Participants will complete a 29-item questionnaire consisting of the Foot and Ankle Ability Measure, which includes a 21-item Activities of Daily Living (ADL) Subscale and an 8-item Sports Subscale.
Each item is rated on a 5-point Likert scale from 0 (unable to perform) to 4 (no difficulty), yielding a potential score of 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale.
The total score is calculated by subtracting the raw score from the maximum possible score, dividing by the maximum score, and multiplying by 100 to determine the percentage of maximum ability achieved.
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at baseline and after 2 months
|
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assessment of functional performance
Time Frame: at baseline and after 2 months
|
The side-hop test involves participants hopping laterally on one limb over a distance of 30 cm for 10 repetitions, with a stopwatch recording the fastest time.
Trials are invalidated if the contralateral foot touches the ground.
After 1-3 practice trials, 3 test trials are conducted, and the average time is used for analysis (Kamonseki et al., 2018).
Additionally, the figure of the hop test requires participants to hop twice around a 5-m cone-marked course as fast as possible, with penalties for footfall or course deviations, and timing recorded to the nearest 0.01 seconds.
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at baseline and after 2 months
|
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assessment of postural control
Time Frame: at baseline and after 2 months
|
The modified star test grid features three lines emanating from a center point, oriented as anterior, posteromedial, and posterolateral.
Participants stand at the center with feet together and perform single-limb squats, reaching towards maximum points along each direction line with the swinging limb.
The participant must lightly touch the line with the distal part of the reaching foot without shifting their weight to it or resting on it.
They must then return the limb to the center while maintaining balance on the stance limb.
Any heavy contact, resting, or shifting during the trial invalidates it.
Maximum reach distances are measured with a tape measure.
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at baseline and after 2 months
|
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assessment of balance
Time Frame: at baseline and after 2 months
|
The "Self-check" mode provides two measurement options for Static Balance Testing and alternative assessments using an Electronic Balance Board.
Participants stand with feet shoulder-width apart (~30 cm) and are monitored via a computer screen displaying a target zone of five concentric circles.
The test includes a 15-second adaptation phase followed by a 20-second measurement period, during which stability is assessed based on how long a tracking ball remains within the inner circle.
Scores range from 1 (Excellent Stability) to 5 (Bad Stability), with lower scores indicating better performance.
Additionally, dynamic tasks require participants to track a target point on-screen, measuring time in the target for scoring.
After the tests, scores for each foot and the overall percentage difference are displayed, with values below 10% indicating good body balance.
|
at baseline and after 2 months
|
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assessment of Dorsiflexion range of motion
Time Frame: at baseline and after 2 months
|
The inclinometer will be fixed to the lateral side of the distal leg just above the ankle joint using a strap.
It should be oriented laterally, and its zero point should be parallel to the floor.
Participant will make dorsiflexion from weightbearing position by proximal segment, the degree of changed range from zero will be appeared on inclinometer
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at baseline and after 2 months
|
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assessment of mental workload
Time Frame: at baseline and after 2 months
|
using the National Aeronautics and Space Administration-Task Load Index questionnaire.
Participants assess the workload of a comprehension task after reading selected texts by answering 10 questions.
A rater evaluates and assigns weights to six scales based on 15 pair-wise comparisons.
Each scale is represented by a line divided into intervals, with descriptors ranging from 'low' to 'high', except for 'performance', which goes from 'good' to 'poor' and is reverse scored.
The overall workload score is computed by multiplying raw ratings by participant weights, summing these, and dividing by 15, resulting in a score from 0 to 100.
|
at baseline and after 2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Neurological Rehabilitation
- Exercise
- Cognitive Training
Other Study ID Numbers
- Manar-PHD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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