- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248475
Effects of Battle Rope Training on ROM and Pain in Children With Post Traumatic Elbow Contractures.
The primary objective of this study is to assess the effectiveness of battle rope training in improving ROM, reducing pain, and enhancing overall elbow function in children with post-traumatic elbow contracture. By comparing standard therapy alone to standard therapy plus battle rope training, the study aims to determine if this added intervention leads to greater improvements in functional mobility and pain relief.In this randomized controlled trial, participants will be divided into two groups: a control group, receiving standard treatment (ROM exercises, stretching, and heat therapy), and an intervention group, receiving the same standard treatment plus battle rope training. ROM exercises and stretching will focus on gentle elbow flexion and extension to enhance flexibility, while heat therapy will prepare muscles for movement.
The intervention group will additionally perform 10-15 minutes of battle rope training, involving dynamic movements that engage the upper body and increase joint activation. Pre- and post-intervention assessments using a goniometer for ROM, the Flynn scoring system for functional and cosmetic outcomes, and the Visual Analogue Scale (VAS) for pain will provide comprehensive data on the effectiveness of the intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Post-traumatic elbow contracture is a common condition in children following elbow injuries, leading to restricted range of motion (ROM), pain, and reduced arm function. Standard treatments often include stretching, heat therapy, and ROM exercises to improve joint mobility and reduce discomfort. However, new approaches such as battle rope training, which is typically used for dynamic strength and endurance, may provide additional benefits by engaging upper body muscles and enhancing functional movement in children with contractures. This study explores whether incorporating battle rope training into a standard rehabilitation program can yield better outcomes than traditional therapy alone.
The primary objective of this study is to assess the effectiveness of battle rope training in improving ROM, reducing pain, and enhancing overall elbow function in children with post-traumatic elbow contracture. By comparing standard therapy alone to standard therapy plus battle rope training, the study aims to determine if this added intervention leads to greater improvements in functional mobility and pain relief.In this randomized controlled trial, participants will be divided into two groups: a control group, receiving standard treatment (ROM exercises, stretching, and heat therapy), and an intervention group, receiving the same standard treatment plus battle rope training. ROM exercises and stretching will focus on gentle elbow flexion and extension to enhance flexibility, while heat therapy will prepare muscles for movement.
The intervention group will additionally perform 10-15 minutes of battle rope training, involving dynamic movements that engage the upper body and increase joint activation. Pre- and post-intervention assessments using a goniometer for ROM, the Flynn scoring system for functional and cosmetic outcomes, and the Visual Analogue Scale (VAS) for pain will provide comprehensive data on the effectiveness of the intervention. This study seeks to offer new insights into pediatric rehabilitation, potentially introducing an effective and engaging therapy option for managing elbow contracture in children
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
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Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Recruiting
- Imran Amjad
-
Contact:
- Muhmmad Asif Javed, MS
- Phone Number: 033224209422
- Email: a.javed@ripah.edu.pk
-
Contact:
- Azlfa Karim, MS*
- Phone Number: 03044333145
- Email: azlfakarim1@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 8 to 15
- Children Suffering from Post-Traumatic Elbow Contracture
- Written informed consent obtained from the parents or guardians
- Participants must report a pain level of at least 3 on a visual analog scale (VAS)
- Children must be able to follow instructions and participate in physical activities.
- Children without any other co-existing illness like Burn Contractures
- Either gender will be included
Exclusion Criteria:
- Post Traumatic Contracture other than Elbow region
- Known allergies to materials used in battle rope training.
- Children who are unable to commit to the training schedule or follow-up assessments.
- Use of medications that may affect pain perception or muscle function, such as opioids or muscle relaxants.
- Burn Contracture.
- Presence of other significant musculoskeletal disorders or neurological conditions affecting the elbow.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Battle Rope Training
Group A will perform Baseline treatment with Battle rope trining.The intervention group will follow the same baseline rehabilitation program of ROM exercises, stretching, and heat therapy as the control group to ensure a consistent foundation for all participants.
However, in addition to these therapies, the intervention group will engage in Battle Rope Training designed to further enhance muscle activation, endurance, and joint mobility.
All five exercises will be performed 5 days a week with 2 sets.A 12.8-m TR (4.1 kg) was used for all trials.
|
All five exercises will be performed 5 days a week with 2 sets.A 12.8-m TR (4.1 kg) was used for all trials Week 1 to 2: During the period the subjects performed 5 selected battle rope exercises.
Each exercises the subjects performed ten seconds with two repetitions.
The total number of set was 2. The recovery for in between exercise 1minute and in between set was 5 minutes.
Week 3 to 4: During the period the subjects performed 5 selected battle rope exercises.
Each exercises the subjects performed twenty seconds with 3 repetitions.
The total number of set was 2. The recovery for in between exercise 1minute and in between set was 5 minutes.
Week 5 to 6: During the period the subjects performed 5 selected battle rope exercises.
Each exercises the subjects performed thirty seconds with 4 repetitions.
The total number of set was 2. The recovery for in between exercise 1minute and in between set was 5 minutes
|
|
Active Comparator: ROM, Stretching and Heat Therapy
The control group will receive Range of Motion (ROM) exercises, stretching, and heat therapy to manage post-traumatic elbow contracture.
ROM Exercises will focus on gentle flexion and extension movements to gradually improve joint mobility .
These exercises will be performed daily.Stretching exercises will target the muscles surrounding the elbow specifically designed to lengthen and relax the soft tissues that may contribute to contracture.
These stretches will be held for 15-30 seconds and repeated several times per session to facilitate flexibility without overstressing the joint.
Heat Therapy will be applied to the affected area .
Heat will be applied for approximately 10-15 minutes.
This combined approach aims to provide standard care that helps alleviate stiffness, manage pain, and improve functional movement over time, without the addition of the battle rope intervention
|
The control group will receive Range of Motion (ROM) exercises, stretching, and heat therapy to manage post-traumatic elbow contracture.
ROM Exercises will focus on gentle flexion and extension movements to gradually improve joint mobility .
These exercises will be performed daily.Stretching exercises will target the muscles surrounding the elbow specifically designed to lengthen and relax the soft tissues that may contribute to contracture.
These stretches will be held for 15-30 seconds and repeated several times per session to facilitate flexibility without overstressing the joint.
Heat Therapy will be applied to the affected area .
Heat will be applied for approximately 10-15 minutes.
This combined approach aims to provide standard care that helps alleviate stiffness, manage pain, and improve functional movement over time, without the addition of the battle rope intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 1st week to 5th week
|
The Visual Analogue Scale (VAS) is used to measure pain intensity in children with post-traumatic elbow contracture (17). A 10 cm line is provided, with 0 cm indicating "no pain" and 10 cm representing the "worst pain imaginable." Children are asked to mark their current pain level on this line. The distance from the "no pain" end to the mark (measured in cm) is recorded as their pain score (0-10). Scoring Interpretation:
|
1st week to 5th week
|
|
ROM using Goniometer
Time Frame: 1st week to 5th week
|
The goniometer is a precise instrument used to measure joint angles and assess the range of motion (ROM) of the elbow(17).It will provide quantifiable data on elbow flexion and extension angles before, during, and after the intervention with battle rope training.
Elbow contracture limits joint movement, so any increase in ROM captured by the goniometer can indicate a positive outcome from the intervention.
For each measurement, the goniometer will be placed along the lateral aspect of the elbow, with one arm aligned along the humerus and the other along the forearm.
The degree of extension and flexion will be measured in a standard position to ensure consistency across multiple sessions.
The goniometer offers objective, reproducible data that will help gauge the effectiveness of battle rope training in improving joint flexibility and reducing the severity of contracture.
Changes in ROM captured across the study period will be key indicators of functional improvements.
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1st week to 5th week
|
|
Flynn Scoring
Time Frame: 1st week to 5th week
|
The Flynn scoring system is used to assess the functional and cosmetic outcomes in pediatric elbow injuries, providing a comprehensive score based on a range of clinical factors.
Flynn scoring will be applied to evaluate improvements in elbow function following battle rope training for children with post-traumatic elbow contracture.
|
1st week to 5th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Azlfa Karim, Riphah International University
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/Azlfakarim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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