Deformity FlexionNCT04491812
Triceps Taping on Elbow Flexion Tightness in Extended Erb's Palsy
A study testing Kinesio Tape and Physical therapy program in people with Deformity Flexion, run by MTI University at 1 site in Egypt.
Trial summary
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Deformity Flexion
- What is being tested?
- Kinesio Tape and Physical therapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2020to 30 Nov 2020
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-6 months of age
- had unilateral extended BPBP involving cervical 5, 6, and 7 roots lesion
- based on an EMG referral by a physiatrist
- had positive grasp reflex on both sides
- had asymmetrical Moro reflex on the affected side.
Who cannot join
- surgical interferences arm fracture or dislocations hypersensitivity to latex and adhesive tapes
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty pf physical therapy, Cairo University
Giza
Radwa S Ahmed, MSc, +201004008503, radwa.said@pt.mti.edu.eg
About this study
Official title: Role of Triceps Kinesiology Taping on Elbow Flexion Tightness in Extended Erb's Palsy Infants
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
Read the detailed description
PURPOSE:
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
BACKGROUND:
BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction, secondary joint corrections, and muscle transpositions are employed to help the child maximize function in the affected upper extremity. Kinesiology taping can have an effect on muscle performance and support joint by improving proprioception, normalizing muscle tone, correct the inappropriate positions and stimulate skin receptors. The possible effect of kinesiotaping on muscle strength has been investigated by numerous researchers that have theorized that kinesiotaping facilitates an immediate increase in muscle strength by generating a concentric pull on the fascia.
HYPOTHESES:
There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
RESEARCH QUESTION:
Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants with extended Erb's palsy?
- Conditions
- Deformity Flexion
- Being tested
- Kinesio Tape, Physical therapy program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapeOther
Elastic Kinesiology Tape
Physical therapy programOther
designed physical therapy program
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotaping | Experimental | kinesiotaping of the triceps muscle applied to the study group alongside the physical therapy program Receives: Other: Kinesio Tape |
| physical therapy program | Placebo comparator | the control group recieved only the physical therapy program Receives: Other: Physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow extension ROM
The range of motion of the extension of the elbow will be measured by smartphone goniometer "G-Pro" and recorded in "degrees"
Measured: 3 months
Secondary outcomes (1)
muscle strength
elbow flexors and extensors muscle strength will be measured using the "Toronto Active Movement Scale" and recorded by number scale from 0-7; 0 meaning no contraction while 7 mean normal power
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start10 Aug 2020
- Primary completion10 Sep 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deformity FlexionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A: physical therapy program Group B: physical therapy program inaddition to kinesiotaping
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Said, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491812
- Sponsor's protocol ID
- P.T.REC/012/001922
- Status last verified
- Sep 2020
- First submitted
- 16 Jul 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Triceps Kinesiology Taping on Elbow Flexion Tightness in Extended Erb's Palsy Infants
- ClinicalTrials.gov ID
- NCT04491812
- Acronym / sponsor ID
- P.T.REC/012/001922
- Conditions
- Deformity Flexion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 10 Sep 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 29 Jul 2020 (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.
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
Detailed description
PURPOSE:
To determine the role of using Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
BACKGROUND:
BACKGROUND Neglecting or even delay in Brachial plexus birth palsy management, may result in substantial and chronic impairment. Physiotherapy, microsurgical nerve reconstruction, secondary joint corrections, and muscle transpositions are employed to help the child maximize function in the affected upper extremity. Kinesiology taping can have an effect on muscle performance and support joint by improving proprioception, normalizing muscle tone, correct the inappropriate positions and stimulate skin receptors. The possible effect of kinesiotaping on muscle strength has been investigated by numerous researchers that have theorized that kinesiotaping facilitates an immediate increase in muscle strength by generating a concentric pull on the fascia.
HYPOTHESES:
There will be no role of Kinesiology tape on the prevention of elbow flexion tightness in infants with extended Erb's palsy.
RESEARCH QUESTION:
Is there a role of using Kinesiology tape in preventing elbow flexion tightness in infants with extended Erb's palsy?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A: physical therapy program Group B: physical therapy program inaddition to kinesiotaping
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping | Experimental | Other: Kinesio Tapekinesiotaping of the triceps muscle applied to the study group alongside the physical therapy program |
| physical therapy program | Placebo comparator | Other: Physical therapy programthe control group recieved only the physical therapy program |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 3-6 months of age
- had unilateral extended BPBP involving cervical 5, 6, and 7 roots lesion
- based on an EMG referral by a physiatrist
- had positive grasp reflex on both sides
- had asymmetrical Moro reflex on the affected side.
Key exclusion criteria (1 listed)
- surgical interferences arm fracture or dislocations hypersensitivity to latex and adhesive tapes
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 |
|---|---|---|
| Kinesio TapeElastic Kinesiology Tape | Other | Kinesiotaping |
| Physical therapy programdesigned physical therapy program | Other | physical therapy program |
Primary outcome
Elbow extension ROM
Time frame: 3 months
The range of motion of the extension of the elbow will be measured by smartphone goniometer "G-Pro" and recorded in "degrees"
1 secondary outcome
muscle strength
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Deformity Flexion
Recruiting
Conservative Treatment With Relative Motion Flexion Orthosis for Boutonniere Injuries in Fingers
Finger Joint Deformities, Tendon Injuries
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Active, not recruitingObservational study
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Knee Pain Chronic, Osteoarthritis, Knee
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Knee Pain Chronic, Osteoarthritis
Active, not recruiting
Cemented vs Cementless Persona Keel RCT
Knee Pain Chronic, Rheumatoid Arthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Tape and Physical therapy program in people with Deformity Flexion, run by MTI University at 1 site in Egypt.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Sep 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Radwa S Ahmed, MSc (+201004008503, radwa.said@pt.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow extension ROM (time frame: 3 months). 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 4 Sep 2020.