NCT05717426

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

January 28, 2023

Last Update Submit

August 11, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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)

    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

    4 weeks

Study Arms (2)

Open chain exercises group

ACTIVE COMPARATOR

Group A(Open chain exercises group) received open kinetic exercises 3 times a week for 3-4 weeks.

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.

Other: Closed kinetic chain exercises

Interventions

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.

Open chain exercises group

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.

Closed kinetic chain exercises group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 18-30years
  • Tennis, Football, Cricketers, volley ball and Hockey players
  • Athletes with balance problems
  • Chronic ankle injuries

You may not qualify if:

  • Acute injuries
  • Non-athletes (minimum once a week sports participation)
  • Athletes with pain related to calf muscles and achillies tendon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan sports board Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Muhammad Ahmed sajjad, MS-SPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

January 28, 2023

Primary Completion

May 30, 2023

Study Completion

July 25, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations