StrokeNCT06067724
Effect of Pelvic Control Exercises in Stroke
A study of Stroke, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men only
- Conditions the study is for
- Stroke
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 May 2023to 7 Apr 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 45 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age will range from 45 - 60 years.
- Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale.
- Duration of illness will range from 6 to 18 months after stroke onset.
- Ability of the patient to stand without assistive devices.
Who cannot join
- • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy.
- Severe chronic back and/or knee pain that might affected standing posture.
- Recurrent stroke
- Shoulder or upper limb injury that might affect the recovery.
- Perceptual or cognitive dysfunctions.
- BMI > 30
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of physical therapy labs at Cairo University
Giza, 12612
- Recruiting
Faculty of physical therapy labs at Cairo University
Giza, 12612
Rowida Abdelgleel, Assistant lecturer, 01152322677, rowidaabdelglel@gmail.com
About this study
Official title: Effect of Pelvic and Trunk Control Exercises on Function Outcome of Affected Upper Extremity in Stroke Patients
The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.
Read the detailed description
The study conducted on forty stroke patients. They assessed by Biodex System 3 Pro Isokinetic, Modified Ashworth Scale(MAS), Fugel Meyer Assessment scale (FMAS), Box and block test and hand grip dynamometer. Patients divided into control group and study group. The control group treated by a traditional physical therapy program.The study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.
- Conditions
- Stroke
- Being tested
- Pelvic and trunk control exercises
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic and trunk control exercisesOther
Patients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic and trunk control exercises for 40 min included abdominal drawing in maneuver for contraction of transversus abdominis pelvic tilting exercises and pelvic stabilization exercises from different positions. Pelvic tilting exercises included; anterior, posterior, lateral pelvic tilting and pelvic rotation on a therapeutic ball. Pelvic stabilization exercises include bridging, half bridging, clamshell from supine and side lying, quadribed exercises, weight shifting on the affected limb from standing by forward and diagonal reach out, ball bridging and rhythmic stabilization exercises
| Study group | Role | What they receive |
|---|---|---|
| Pelvic and trunk control exercises | Active comparator | Twenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program. Receives: Other: Pelvic and trunk control exercises |
| Traditional physical therapy | Sham comparator | Twenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks. Receives: Other: Pelvic and trunk control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex System 3 Pro Isokinetic
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention
Measured: Six weeks after the beginning of the intervention
Secondary outcomes (3)
Fugl-Meyer Assessment for upper extremity
Changes in upper limb function from baseline to four weeks after the beginning of intervention
Measured: Six weeks after the beginning of the intervention
Box and block test
Changes in gross hand function from baseline to four weeks after the beginning of intervention
Measured: Six weeks after the beginning of the intervention
Hand grip dynamometer
. Changes in hand grip strength from baseline to four weeks after the beginning of intervention
Measured: Six weeks after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start20 May 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion7 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowida Abd Elgleel Sayed Abd Elgleel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067724
- Sponsor's protocol ID
- Pelvic control in stroke
- Status last verified
- Apr 2024
- First submitted
- 28 Sep 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic and Trunk Control Exercises on Function Outcome of Affected Upper Extremity in Stroke Patients
- ClinicalTrials.gov ID
- NCT06067724
- Acronym / sponsor ID
- Pelvic control in stroke
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 7 Apr 2024 (estimated)
- First posted
- 5 Oct 2023 (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.
The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.
Detailed description
The study conducted on forty stroke patients. They assessed by Biodex System 3 Pro Isokinetic, Modified Ashworth Scale(MAS), Fugel Meyer Assessment scale (FMAS), Box and block test and hand grip dynamometer. Patients divided into control group and study group. The control group treated by a traditional physical therapy program.The study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic and trunk control exercises | Active comparator | Other: Pelvic and trunk control exercisesTwenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program. |
| Traditional physical therapy | Sham comparator | Other: Pelvic and trunk control exercisesTwenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's age will range from 45 - 60 years.
- Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale.
- Duration of illness will range from 6 to 18 months after stroke onset.
- Ability of the patient to stand without assistive devices.
Key exclusion criteria (6 listed)
- • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy.
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 |
|---|---|---|
| Pelvic and trunk control exercisesPatients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic and trunk control exercises for 40 min included abdominal drawing in maneuver for contraction of transversus abdominis pelvic tilting exercises and pelvic stabilization exercises from different positions. Pelvic tilting exercises included; anterior, posterior, lateral pelvic tilting and pelvic rotation on a therapeutic ball. Pelvic stabilization exercises include bridging, half bridging, clamshell from supine and side lying, quadribed exercises, weight shifting on the affected limb from standing by forward and diagonal reach out, ball bridging and rhythmic stabilization exercises | Other | Pelvic and trunk control exercises, Traditional physical therapy |
Primary outcome
Biodex System 3 Pro Isokinetic
Time frame: Six weeks after the beginning of the intervention
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention
3 secondary outcomes
Fugl-Meyer Assessment for upper extremity
Time frame: Six weeks after the beginning of the intervention
Box and block test
Time frame: Six weeks after the beginning of the intervention
Hand grip dynamometer
Time frame: Six weeks after the beginning of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke, run by Cairo University at 2 sites 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 4 inclusion and 6 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rowida Abdelgleel, Assistant lecturer (01152322678, rowidaabdelglel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex System 3 Pro Isokinetic (time frame: Six weeks after the beginning of the intervention). 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 8 Apr 2024.