Neck of Femur FractureNCT06901843
Comparative Effects of Closed Kinetic Chain Exercises and Mobilization Exercises in Elderly Females With NFF
A study testing Mobilizations Exercises and Closed Kinetic Chain Exercises in people with Neck of Femur Fracture, run by Superior University at 1 site in Pakistan.
Trial summary
This study investigates the additional benefits of Mobilization Exercises and Closed Kinetic Chain Exercises (CKCE) in elderly individuals with post-operative neck of femur fracture. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Neck of Femur Fracture
- What is being tested?
- Mobilizations Exercises and Closed Kinetic Chain Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosed by Orthopedic Surgeon with neck of femur fracture by x ray findings
- Patients undergone surgical treatment for neck of femur fracture within one year.
- Patients administer in groups after 12 weeks of post-operative period
- X-ray reexamination with no fracture or dislocation before treatment
- Ability to walk normally or with crutches
- Patients walk without any assistance before injury
Show all 10Show fewer
- Un-displaced neck of femur fracture according to Garden Classification
- Operated on using internal fixation
- Only females were included
- Aged 65 years or older
Who cannot join
- Bilateral hip fracture
- Bedridden patient before fracture
- Patient who have undergone any previous surgery of lower limb
- Neurological Condition
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bajwa hospital J7JP+4WH, GT Rd, Shahdara Town, Shahdara
Lahore, Punjab Province, 03155419544
About this study
Official title: Comparative Effects of Closed Kinetic Chain Exercises and Mobilization Exercises in Elderly Females With Neck of Femur Fracture
This study investigates the additional benefits of Mobilization Exercises and Closed Kinetic Chain Exercises (CKCE) in elderly individuals with post-operative neck of femur fracture. The researcher employs a randomized controlled trial which will involve 49 participants aged above 65 years with post-operative neck of femur fracture.
Read the detailed description
Participants are divided into two groups:
one receiving Mobilization Exercises, and the other receiving Closed Kinetic Chain Exercises. Outcomes are assessed over a 6 week period, focusing on pain intensity, Range of motion, risk of fall by goniometer, visual analogue scale (VAS) and dynamic gait index (DGI) scores. Data will be analyzed using SPSS-23. The study will conclude whether CKCE or Mobilization exercises offer a significant benefit in pain reduction, prevent risk of falls and range of motion.
- Conditions
- Neck of Femur Fracture
- Being tested
- Mobilizations Exercises, Closed Kinetic Chain Exercises
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilizations ExercisesCombination product
Group A was treated with mobilizations exercises for 40 minutes for 3 sessions per week for 6 weeks. Patients received hip mobilizations. Therapist perform anterior posterior glide, caudal glide, posterior anterior glide with abduction, flexion and lateral rotation in 3 sets with 10 repetitions .Mobilization grades were performed according to patients tolerance level with duration 30-second rest .Hip strengthening exercises were performed 3 sets with 10 repetition with hip abduction in side lying, hip extension in prone position, sideway walk, hip abduction in a stand up position.
Closed Kinetic Chain ExercisesCombination product
Group B was treated with Closed Kinetic Chain Exercises for 40 minutes for 3 sessions per week for 6 weeks. Closed kinetic chain exercises were performed with 5 minute break between each exercise. Leg press in horizontal position ,Stationary bicycling and Stairmaster climbing.
| Study group | Role | What they receive |
|---|---|---|
| Mobilizations Exercises | Experimental | Not described Receives: Combination Product: Mobilizations Exercises |
| Closed Kinetic Chain Exercises | Active comparator | Not described Receives: Combination Product: Closed Kinetic Chain Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The 10-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". The VAS is a valid and reliable scale to measure pain intensity. VAS demonstrates strong correlation validity with other established pain measurement scales, making it a reliable tool for clinical assessments. Validity is 0.88 % and Reliability is 0.90%.
Measured: 12 Months
Dynamic Gait Index (DGI)
The questionnaire has been designed to evaluate risk of fall and balance during dynamic tasks. DGI includes 8 items, score between 0-3 scales. Score of 0 indicates severe impairment and score of 3 indicates normal function. Total score is between 0-24. Validity is 0.88% and Reliability is 0.97%. Interpretation 0-11: Severe impairment 12-19: Moderate impairment 20-24: Mild impairment
Measured: 12 months
GONIOMETER
Goniometer is used to measure the joint angle in degrees, ROM and flexibility. The goniometer measures ranges and degrees of joints. The range of goniometer is typically 0-180 degrees or o-360 degrees. The intervals on scale can vary from 0-10 degrees. Hip Joint Ranges of Motion
- Flexion: 120-130 degrees
- Extension: 10-20 degrees
- Abduction: 40-50 degrees
- Adduction: 20-30 degrees
- Internal Rotation: 30-40 degrees
- External Rotation: 40-50 degrees
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start20 Mar 2025
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck of Femur FractureStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901843
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/778
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Closed Kinetic Chain Exercises and Mobilization Exercises in Elderly Females With Neck of Femur Fracture
- ClinicalTrials.gov ID
- NCT06901843
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/778
- Conditions
- Neck of Femur Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 30 Mar 2025 (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.
This study investigates the additional benefits of Mobilization Exercises and Closed Kinetic Chain Exercises (CKCE) in elderly individuals with post-operative neck of femur fracture. The researcher employs a randomized controlled trial which will involve 49 participants aged above 65 years with post-operative neck of femur fracture.
Detailed description
Participants are divided into two groups:
one receiving Mobilization Exercises, and the other receiving Closed Kinetic Chain Exercises. Outcomes are assessed over a 6 week period, focusing on pain intensity, Range of motion, risk of fall by goniometer, visual analogue scale (VAS) and dynamic gait index (DGI) scores. Data will be analyzed using SPSS-23. The study will conclude whether CKCE or Mobilization exercises offer a significant benefit in pain reduction, prevent risk of falls and range of motion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilizations Exercises | Experimental | Combination Product: Mobilizations Exercises |
| Closed Kinetic Chain Exercises | Active comparator | Combination Product: Closed Kinetic Chain Exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Diagnosed by Orthopedic Surgeon with neck of femur fracture by x ray findings
- Patients undergone surgical treatment for neck of femur fracture within one year.
- Patients administer in groups after 12 weeks of post-operative period
- X-ray reexamination with no fracture or dislocation before treatment
- Ability to walk normally or with crutches
Key exclusion criteria (4 listed)
- Bilateral hip fracture
- Bedridden patient before fracture
- Patient who have undergone any previous surgery of lower limb
- Neurological Condition
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 |
|---|---|---|
| Mobilizations ExercisesGroup A was treated with mobilizations exercises for 40 minutes for 3 sessions per week for 6 weeks. Patients received hip mobilizations. Therapist perform anterior posterior glide, caudal glide, posterior anterior glide with abduction, flexion and lateral rotation in 3 sets with 10 repetitions .Mobilization grades were performed according to patients tolerance level with duration 30-second rest .Hip strengthening exercises were performed 3 sets with 10 repetition with hip abduction in side lying, hip extension in prone position, sideway walk, hip abduction in a stand up position. | Combination product | Mobilizations Exercises |
| Closed Kinetic Chain ExercisesGroup B was treated with Closed Kinetic Chain Exercises for 40 minutes for 3 sessions per week for 6 weeks. Closed kinetic chain exercises were performed with 5 minute break between each exercise. Leg press in horizontal position ,Stationary bicycling and Stairmaster climbing. | Combination product | Closed Kinetic Chain Exercises |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 12 Months
The 10-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". The VAS is a valid and reliable scale to measure pain intensity. VAS demonstrates strong correlation validity with other established pain measurement scales, making it a reliable tool for clinical assessments. Validity is 0.88 % and Reliability is 0.90%.
Dynamic Gait Index (DGI)
Time frame: 12 months
The questionnaire has been designed to evaluate risk of fall and balance during dynamic tasks. DGI includes 8 items, score between 0-3 scales. Score of 0 indicates severe impairment and score of 3 indicates normal function. Total score is between 0-24. Validity is 0.88% and Reliability is 0.97%. Interpretation 0-11: Severe impairment 12-19: Moderate impairment 20-24: Mild impairment
GONIOMETER
Time frame: 12 months
Goniometer is used to measure the joint angle in degrees, ROM and flexibility. The goniometer measures ranges and degrees of joints. The range of goniometer is typically 0-180 degrees or o-360 degrees. The intervals on scale can vary from 0-10 degrees. Hip Joint Ranges of Motion 1. Flexion: 120-130 degrees 2. Extension: 10-20 degrees 3. Abduction: 40-50 degrees 4. Adduction: 20-30 degrees 5. Internal Rotation: 30-40 degrees 6. External Rotation: 40-50 degrees
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilizations Exercises and Closed Kinetic Chain Exercises in people with Neck of Femur Fracture, run by Superior University 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analogue Scale (VAS) (time frame: 12 Months). The study lists 3 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 30 Mar 2025.