Effects of Hip Strength Training and Neuromuscular Electrical Stimulation on Functional Ankle Instability

NCT ID: NCT06125158

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2023-12-23

Brief Summary

The goal of this clinical trial is to compare the effects of two methods of elevating hip muscle strength on functional ankle instability(FAI). . The main question[s] it aims to answer are:

• Whether hip strength training and neuromuscular electrical stimulation of the gluteal muscles, respectively, based on conventional ankle training improves dysfunction in patients with FAI?
• Is there a difference in the efficacy of the above two interventions for FAI?

Detailed Description

Participants will be randomly divided into 3 groups (Experimental Group A, Experimental Group B and Control Group) to receive the intervention for 6 weeks. The Control Group will undergo conventional ankle interventions such as peri-ankle muscle strength training and ankle balance training; Experimental Group A will undergo hip muscle strength training based on the conventional training; and Experimental Group B will perform neuromuscular electrical stimulation of hip abductors and hip extensors based on the conventional training. Researchers will compare the three groups to see changes in hip muscle strength, lower extremity muscle activation, ankle muscle strength, proprioception, dynamic and static balance, and self-reported ankle function.

Conditions

Ankle Injuries and Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants in this group will receive conventional ankle interventions including ankle strength training and balance training. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Conventional ankle training

Intervention Type: PROCEDURE

The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.

Experimental Group A

Participants in this group will be asked to perform conventional ankle training and hip strength training. The conventional ankle training routine for this group will have the same movements as the control group, but the volume of training will be half that of the control group, and the duration of training will be 20 min/session. Hip strength training will consist of elastic band resistance exercises, forward step-up and lateral step-up for 20 min/session. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.

Group Type: EXPERIMENTAL

Conventional ankle training

Intervention Type: PROCEDURE

The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.

Hip strength training

Intervention Type: PROCEDURE

Hip strength training required subjects to complete resistance training in hip abduction and posterior extension, anterior step-up and lateral step-up exercises with the help of elastic bands.

Experimental Group B

Participants in this group will be asked to perform conventional ankle training and neuromuscular electrical stimulation. The conventional ankle training routine for this group will have the same movements as the control group, but the volume of training will be half that of the control group, and the duration of training will be 20 min/session. Neuromuscular electrical stimulation aims to stimulate the gluteus maximus and gluteus mediums muscles of the affected lower limb. The researcher chose the "Neuromuscular Electrical Stimulation 1" mode for the treatment prescription (this prescription can output a variety of waveforms with frequencies varying continuously from 1 to 100 Hz to stimulate the target muscles alternately, effectively preventing muscle fatigue caused by a single stimulation) and set the stimulation time to 20 min per session. All treatments target the affected lower extremity for 40 minutes per session, once per day, 3 days per week for 6 weeks.

Group Type: EXPERIMENTAL

Conventional ankle training

Intervention Type: PROCEDURE

The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.

Neuromuscular electrical stimulation

Intervention Type: PROCEDURE

Neuromuscular electrical stimulation of the gluteus mediums and gluteus maximus muscles of the affected side was carried out using the TB6807 low-frequency therapeutic instrument (with prescription for neuromuscular electrical stimulation) manufactured by China Tangbang Science and Technology Company.

Interventions

Conventional ankle training

The program included ankle elastic band resistance training and balance training, in which the elastic band resistance training required subjects to complete resistance training in ankle plantarflexion, dorsiflexion, inversion and eversion directions with the help of elastic bands; and the balance training required subjects to complete the movements of standing with eyes open, standing with eyes closed, and throwing and catching the ball on flat ground and BOSU ball.

Intervention Type: PROCEDURE

Hip strength training

Hip strength training required subjects to complete resistance training in hip abduction and posterior extension, anterior step-up and lateral step-up exercises with the help of elastic bands.

Intervention Type: PROCEDURE

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation of the gluteus mediums and gluteus maximus muscles of the affected side was carried out using the TB6807 low-frequency therapeutic instrument (with prescription for neuromuscular electrical stimulation) manufactured by China Tangbang Science and Technology Company.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• History of at least one acute ankle sprain one year ago, accompanied by symptoms such as pain, swelling, and inability to participate in daily activities for more than one day.
• Unilateral ankle sprains and or instability felt at least twice during the past year.
• Last ankle sprain occurred greater than or equal to 1 month from the start of the experiment.
• Cumberland Ankle Instability Tool (CAIT) score less than or equal to 27 points,
• The results of Medial Talar Tilt Test and Anterior Draw Test are negative.
• Body Mass Index （BMI）ranges from 18 to 25.

Exclusion Criteria

• History of lower extremity surgery or fracture.
• History of brain injury or neurological disorders.
• Acute injury to musculoskeletal structures of other joints of the lower extremities within 1 month, affecting joint integrity and function.
• Participated in lower extremity rehabilitation or systematic athletic training after injury.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin University of Sport

OTHER

Sponsor Role: lead

Responsible Party

Yanhua, Guo

student enrolled in a master's program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Zheng, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin University of Sport

Locations

Tianjin University of Sport

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

TianjinSport

Identifier Type: -

Identifier Source: org_study_id