FractureNCT06198088
Effects of PNF Technique in Children With Post Fracture Elbow Stiffness
A study testing PNF techniques and Exercise therapy in people with Fracture, run by Riphah International University at 1 site in Pakistan.
Trial summary
Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Fracture
- What is being tested?
- PNF techniques and Exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 2024
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children Age 3-7 years
- Either gender
- Contracture 4-8 weeks post traumatic injuries.
- Post-operative
Who cannot join
- Burn contracture
- Contracture due to neurological conditions
- Dupytren's contracture, Volkmann's contracture etc.
- Contracture more than 8 week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proprioception Neuromuscular Facilitation Technique in Children With Post Fracture Elbow Stiffness
Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Proprioceptive Neuromuscular Facilitation is a stretching technique utilized to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions. In clinical settings, PNF is already utilized by therapists to restore functional range of motion (ROM) and increase strength in patients who have sustained soft tissue damage or received invasive surgeries.
Read the detailed description
This Randomized clinical trial study will be conducted in THQ hospital Arifwala/DHQ pakpattan with calculated sample size 26. Study will be approved by ethical committee. After that informed consent will be taken and patients will be randomly assigned to (Group A) control group these individuals will receive Maitland's mobilization with everyday object activities (Group B) experimental group (these individuals will receive baseline treatment and PNF technique ) frequency will be 5 session per week of 30 min and duration is of 4 weeks. Ranges will be assessed by Goniometry DASH outcome measure scale will use to assess functional activity. Data will be analyzed by SPSS latest version.
- Conditions
- Fracture
- Being tested
- PNF techniques, Exercise therapy
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF techniquesOther
The patient in the experiment group will PNF techniques (hold relax) the participants who were assigned for post traumatic stiffness of the elbow with baseline treatment (heating pad), stretching applied for 30 sec then relaxation time 10 sec, 5 repetition were given in a session for 5 days a week for 4 weeks.
Exercise therapyOther
exercise therapy range of motion, stretching and strengthening were applied with heating pad as baseline treatment. 5 repetition were given in a session for 5 days a week for 4 week.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The patient in the experiment group will PNF techniques (hold relax) the participants who were assigned for post traumatic stiffness of the elbow with baseline treatment (heating pad), stretching applied for 30 sec then relaxation time 10 sec, 5 repetition were given in a session for 5 days a week for 4 weeks. Receives: Other: PNF techniques |
| control group | Other | exercise therapy range of motion, stretching and strengthening were applied with heating pad as baseline treatment. 5 repetition were given in a session for 5 days a week for 4 week. Receives: Other: Exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of upper limbs.
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 posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumaira Bibi, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198088
- Sponsor's protocol ID
- REC/RCR&AHS/23/0744
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sim G, Fleming J, Glasgow C. Mobilizing orthoses in the management of post-traumatic elbow contractures: A survey of Australian hand therapy practice. J Hand Ther. 2021 Jan-Mar;34(1):90-99. doi: 10.1016/j.jht.2019.12.014. Epub 2020 Mar 7.
PubMed 32156579
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioception Neuromuscular Facilitation Technique in Children With Post Fracture Elbow Stiffness
- ClinicalTrials.gov ID
- NCT06198088
- Acronym / sponsor ID
- REC/RCR&AHS/23/0744
- Conditions
- Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (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.
Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Proprioceptive Neuromuscular Facilitation is a stretching technique utilized to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions. In clinical settings, PNF is already utilized by therapists to restore functional range of motion (ROM) and increase strength in patients who have sustained soft tissue damage or received invasive surgeries.
Detailed description
This Randomized clinical trial study will be conducted in THQ hospital Arifwala/DHQ pakpattan with calculated sample size 26. Study will be approved by ethical committee. After that informed consent will be taken and patients will be randomly assigned to (Group A) control group these individuals will receive Maitland's mobilization with everyday object activities (Group B) experimental group (these individuals will receive baseline treatment and PNF technique ) frequency will be 5 session per week of 30 min and duration is of 4 weeks. Ranges will be assessed by Goniometry DASH outcome measure scale will use to assess functional activity. Data will be analyzed by SPSS latest version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: PNF techniquesThe patient in the experiment group will PNF techniques (hold relax) the participants who were assigned for post traumatic stiffness of the elbow with baseline treatment (heating pad), stretching applied for 30 sec then relaxation time 10 sec, 5 repetition were given in a session for 5 days a week for 4 weeks. |
| control group | Other | Other: Exercise therapyexercise therapy range of motion, stretching and strengthening were applied with heating pad as baseline treatment. 5 repetition were given in a session for 5 days a week for 4 week. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children Age 3-7 years
- Either gender
- Contracture 4-8 weeks post traumatic injuries.
- Post-operative
Key exclusion criteria (4 listed)
- Burn contracture
- Contracture due to neurological conditions
- Dupytren's contracture, Volkmann's contracture etc.
- Contracture more than 8 week
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 |
|---|---|---|
| PNF techniquesThe patient in the experiment group will PNF techniques (hold relax) the participants who were assigned for post traumatic stiffness of the elbow with baseline treatment (heating pad), stretching applied for 30 sec then relaxation time 10 sec, 5 repetition were given in a session for 5 days a week for 4 weeks. | Other | experimental group |
| Exercise therapyexercise therapy range of motion, stretching and strengthening were applied with heating pad as baseline treatment. 5 repetition were given in a session for 5 days a week for 4 week. | Other | control group |
Primary outcome
DASH
Time frame: 4 weeks
DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of upper limbs.
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 13 Jun 2024.
- Background: PubMed 32156579Sim G, Fleming J, Glasgow C. Mobilizing orthoses in the management of post-traumatic elbow contractures: A survey of Australian hand therapy practice. J Hand Ther. 2021 Jan-Mar;34(1):90-99. doi: 10.1016/j.jht.2019.12.014. Epub 2020 Mar 7.
- Mobilizing orthoses in the management of post-traumatic elbow contracturesLink provided by the sponsor.
- 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.
Sumaira Bibi, MS* 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 PNF techniques and Exercise therapy in people with Fracture, run by Riphah International 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 4 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
DASH (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198088, which also lists 1 linked publication.
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 13 Jun 2024.