Ankle InjuriesNCT05717426
The Effects of Open Versus Closed Kinetic Chain Exercises on Ankle Joint Function
A study testing Open chain exercises and Closed kinetic chain exercises in people with Ankle Injuries, run by Sehat Medical Complex at 1 site in Pakistan.
Trial summary
The goal of this Randomized clinical trial is to find the effects of open versus closed kinetic chain exercises on ankle joint function in athletes with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Open chain exercises and Closed kinetic chain exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jan 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Age 18-30years
- Tennis, Football, Cricketers, volley ball and Hockey players
- Athletes with balance problems
- Chronic ankle injuries
Who cannot join
- Acute injuries
- Non-athletes (minimum once a week sports participation)
- Athletes with pain related to calf muscles and achillies tendon
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Open Versus Closed Kinetic Chain Exercises on Ankle Joint Function in Athletes With Chronic Ankle Instability
The goal of this Randomized clinical trial is to find the effects of open versus closed kinetic chain exercises on ankle joint function in athletes with chronic ankle instability. The main question it aims to answer is:
- To compare the effects of open versus closed kinetic chain exercises on pain, instability and balance in athletes with chronic ankle instability.
Participants were given consent form and after subjects read and signed the informed consent and completed the self-reported questionnaires designed to identify subjects with CHRONIC ANKLE INSTABILITY, subjects completed baseline measurements that included Foot and Ankle Ability Measure (FAAM)-Sport Subscale, Reach distance, and SEBT. Participant were divided into two groups (Group A and Group B) through lottery method. Group A received open kinetic exercises 3times a week for 3-4 weeks. Group B received close kinetic exercises 3 times a week for 3-4 weeks.
Read the detailed description
Chronic instability is a common condition in sports and there are many treatment methods and rehabilitation protocols available which are used according to extent of injury. The purpose of this study is to find out the effects of close kinetic chain exercises and open kinetic chain exercises and to find out which technique is more efficient for treating ankle instability, pain, and imbalance in athletes with chronic ankle instability. This study will help physical therapists and medical team to enhance the rehabilitation process.
The study was randomized clinical trial conducted at Pakistan Sports board Lahore in which convenient random sampling technique was used. This study included total 26 participants and for this purpose Open Epi tool would be used as a sample size calculation. Participants falling in this category were recruited into the study after inclusion and exclusion criteria. The Cumberland ankle instability tool was used as a tool for pre and post assessment of athletes. In this study we divided population into two groups. Group A received open chain kinetic exercises and Group B was treated with Closed chain kinetic exercises. Data was analyzed through SPSS 25 version.
- Conditions
- Ankle Injuries
- Being tested
- Open chain exercises, Closed kinetic chain exercises
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open chain exercisesOther
An open chain exercise is one that allows the furthest part of the chain to move freely. For example, picking up a glass of water is an open-chain exercise. The hand affects the elbow and the shoulder as it is not fixed in place. However, it does not effect the rest of your body.
Closed kinetic chain exercisesOther
Closed Kinetic Chain (CKC) exercises or closed chain exercises are exercises or movements where the distal aspect of the extremity is fixed to an object that is stationary.
| Study group | Role | What they receive |
|---|---|---|
| Open chain exercises group | Active comparator | Group A(Open chain exercises group) received open kinetic exercises 3 times a week for 3-4 weeks. Receives: Other: Open chain exercises |
| Closed kinetic chain exercises group | Active comparator | Group B(Closed kinetic chain exercises group) received close kinetic exercises 3 times a week for 3-4 weeks. Receives: Other: Closed kinetic chain exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The Numeric Pain Rating Scale (NPRS) is commonly used to assess pain. Change in the NPRS across time can be interpreted with responsiveness indices.
Measured: 4 weeks
Star excursion balance test.
The SEBTs are functional tests that incorporate a single-leg stance on one leg with maximum reach of the opposite leg. The SEBTs are performed with the subject standing at the center of a grid placed on the floor, with 8 lines extending at 45° increments from the center of the grid. The 8 lines positioned on the grid are labeled according to the direction of excursion relative to the stance leg: anterolateral (AL), anterior (A), anteromedial (AM), medial (M), posteromedial (PM), posterior (P), posterolateral (PL), and lateral (L). The grid was constructed in an athletic training facility using a protractor and 3-in (7.62-cm)-wide adhesive tape and was enclosed in a 182.9-cm by 182.9-cm square on the hard tile floor.
Measured: 4 weeks
Reach distance. (functional reach test)
Functional Reach (standing instructions): The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted.
Measured: 4 weeks
Cumberland Ankle Instability Tool (CHRONIC ANKLE INSTABILITYT) and Ankle Instability Instrument (AII)
The Cumberland Ankle Instability Tool (CHRONIC ANKLE INSTABILITYT) is a PROM that can detect functional ankle instability and provide a measure of the severity of the instability . It does so through nine questions evaluating ankle pain, subjective instability during activities such as running or hopping and the ability of the ankle to cope with episodes of giving way . The answers for the nine questions are added up to a total score, which goes from 0 (indicating an extreme functional instability of the ankle) to 30 points (indicating a stable ankle)
Measured: 4 weeks
Foot and Ankle Ability Measure (FAAM)-Sport Subscale
The Foot and Ankle Ability Measure (FAAM) is a patient-reported questionnaire for patients with muscu loskeletal foot and ankle disorders consisting of two sub scales, ADL and Sports, with a total of 32 questions. The FAAM is an evaluative self-reported instrument to comprehensively assess physical function of individu als with musculoskeletal disorders of the foot and ankle. It consists of an ADL (FAAM-ADL) and Sports (FAAM-Sport) subscale, containing 21 and 9 items, respectively. Standardized answer options are given in five-point Likert boxes, ranging from 0 (no difficulty at all) to 4 (unable to do). The sixth option is 'not applicable, which will not be taken into account when counting the percentage scores. According to Martin et al. we only calculated a total subscale if ≤2 items were missing (or inapplicable) in the FAAM-ADL and if ≤1 item was missing (or inapplicable) in the FAAM-Sport domain. A higher score represents a higher level of function in each subscale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start28 Jan 2023
- Primary completion30 May 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Muhammad Ahmed sajjad, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717426
- Sponsor's protocol ID
- ahmadsajjad0446
- Status last verified
- Aug 2023
- First submitted
- 28 Jan 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Open Versus Closed Kinetic Chain Exercises on Ankle Joint Function in Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT05717426
- Acronym / sponsor ID
- ahmadsajjad0446
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Randomized clinical trial is to find the effects of open versus closed kinetic chain exercises on ankle joint function in athletes with chronic ankle instability. The main question it aims to answer is:
- To compare the effects of open versus closed kinetic chain exercises on pain, instability and balance in athletes with chronic ankle instability.
Participants were given consent form and after subjects read and signed the informed consent and completed the self-reported questionnaires designed to identify subjects with CHRONIC ANKLE INSTABILITY, subjects completed baseline measurements that included Foot and Ankle Ability Measure (FAAM)-Sport Subscale, Reach distance, and SEBT. Participant were divided into two groups (Group A and Group B) through lottery method. Group A received open kinetic exercises 3times a week for 3-4 weeks. Group B received close kinetic exercises 3 times a week for 3-4 weeks.
Detailed description
Chronic instability is a common condition in sports and there are many treatment methods and rehabilitation protocols available which are used according to extent of injury. The purpose of this study is to find out the effects of close kinetic chain exercises and open kinetic chain exercises and to find out which technique is more efficient for treating ankle instability, pain, and imbalance in athletes with chronic ankle instability. This study will help physical therapists and medical team to enhance the rehabilitation process.
The study was randomized clinical trial conducted at Pakistan Sports board Lahore in which convenient random sampling technique was used. This study included total 26 participants and for this purpose Open Epi tool would be used as a sample size calculation. Participants falling in this category were recruited into the study after inclusion and exclusion criteria. The Cumberland ankle instability tool was used as a tool for pre and post assessment of athletes. In this study we divided population into two groups. Group A received open chain kinetic exercises and Group B was treated with Closed chain kinetic exercises. Data was analyzed through SPSS 25 version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open chain exercises group | Active comparator | Other: Open chain exercisesGroup A(Open chain exercises group) received open kinetic exercises 3 times a week for 3-4 weeks. |
| Closed kinetic chain exercises group | Active comparator | Other: Closed kinetic chain exercisesGroup B(Closed kinetic chain exercises group) received close kinetic exercises 3 times a week for 3-4 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Age 18-30years
- Tennis, Football, Cricketers, volley ball and Hockey players
- Athletes with balance problems
- Chronic ankle injuries
Key exclusion criteria (3 listed)
- Acute injuries
- Non-athletes (minimum once a week sports participation)
- Athletes with pain related to calf muscles and achillies tendon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open chain exercisesAn open chain exercise is one that allows the furthest part of the chain to move freely. For example, picking up a glass of water is an open-chain exercise. The hand affects the elbow and the shoulder as it is not fixed in place. However, it does not effect the rest of your body. | Other | Open chain exercises group |
| Closed kinetic chain exercisesClosed Kinetic Chain (CKC) exercises or closed chain exercises are exercises or movements where the distal aspect of the extremity is fixed to an object that is stationary. | Other | Closed kinetic chain exercises group |
Primary outcome
Numeric pain rating scale
Time frame: 4 weeks
The Numeric Pain Rating Scale (NPRS) is commonly used to assess pain. Change in the NPRS across time can be interpreted with responsiveness indices.
Star excursion balance test.
Time frame: 4 weeks
The SEBTs are functional tests that incorporate a single-leg stance on one leg with maximum reach of the opposite leg. The SEBTs are performed with the subject standing at the center of a grid placed on the floor, with 8 lines extending at 45° increments from the center of the grid. The 8 lines positioned on the grid are labeled according to the direction of excursion relative to the stance leg: anterolateral (AL), anterior (A), anteromedial (AM), medial (M), posteromedial (PM), posterior (P), posterolateral (PL), and lateral (L). The grid was constructed in an athletic training facility using a protractor and 3-in (7.62-cm)-wide adhesive tape and was enclosed in a 182.9-cm by 182.9-cm square on the hard tile floor.
Reach distance. (functional reach test)
Time frame: 4 weeks
Functional Reach (standing instructions): The patient is instructed to next to, but not touching, a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the 3rd metacarpal head on the yardstick. Instruct the patient to "Reach as far as you can forward without taking a step." The location of the 3rd metacarpal is recorded. Scores are determined by assessing the difference between the start and end position is the reach distance, usually measured in inches. Three trials are done and the average of the last two is noted.
Cumberland Ankle Instability Tool (CHRONIC ANKLE INSTABILITYT) and Ankle Instability Instrument (AII)
Time frame: 4 weeks
The Cumberland Ankle Instability Tool (CHRONIC ANKLE INSTABILITYT) is a PROM that can detect functional ankle instability and provide a measure of the severity of the instability . It does so through nine questions evaluating ankle pain, subjective instability during activities such as running or hopping and the ability of the ankle to cope with episodes of giving way . The answers for the nine questions are added up to a total score, which goes from 0 (indicating an extreme functional instability of the ankle) to 30 points (indicating a stable ankle)
Foot and Ankle Ability Measure (FAAM)-Sport Subscale
Time frame: 4 weeks
The Foot and Ankle Ability Measure (FAAM) is a patient-reported questionnaire for patients with muscu loskeletal foot and ankle disorders consisting of two sub scales, ADL and Sports, with a total of 32 questions. The FAAM is an evaluative self-reported instrument to comprehensively assess physical function of individu als with musculoskeletal disorders of the foot and ankle. It consists of an ADL (FAAM-ADL) and Sports (FAAM-Sport) subscale, containing 21 and 9 items, respectively. Standardized answer options are given in five-point Likert boxes, ranging from 0 (no difficulty at all) to 4 (unable to do). The sixth option is 'not applicable, which will not be taken into account when counting the percentage scores. According to Martin et al. we only calculated a total subscale if ≤2 items were missing (or inapplicable) in the FAAM-ADL and if ≤1 item was missing (or inapplicable) in the FAAM-Sport domain. A higher score represents a higher level of function in each subscale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Ahmed sajjad, MS-SPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open chain exercises and Closed kinetic chain exercises in people with Ankle Injuries, run by Sehat Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.