Strokes ThromboticNCT06679699
Patient Education Program and Trunk Control Exercises in Post-stroke
A study of Strokes Thrombotic, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The trunk movement awareness and education of individuals with post-stroke hemiparesis is not emphasized adequately in clinical practice. Therefore, this current study was made to hypothesize whether a patient education program about dynamic trunk control exercises during stroke rehabilitation may influence trunk… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Strokes Thrombotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Dec 2020to 16 Oct 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ischemic stroke
- Grade 1 - 2 Spasticity
- Hemiparesis
Who cannot join
- Moderate to severe cognitive deficits,
- Alzheimer's disease,
- Language difficulties,
- Unstable blood pressure
- Uncontrolled epilepsy,
- Dislocations/fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Effectiveness of Patient Education Program About Trunk Control Exercises on Balance and Functional Mobility in Individuals With Post-stroke Hemiparesis: A Randomized Control Trial"
The trunk movement awareness and education of individuals with post-stroke hemiparesis is not emphasized adequately in clinical practice. Therefore, this current study was made to hypothesize whether a patient education program about dynamic trunk control exercises during stroke rehabilitation may influence trunk control. 40 individuals with post-stroke hemiparesis were recruited and randomly allocated to the experimental and control group. Both the groups received 1 hour of exercises focusing more on dynamic trunk control exercises with patient education chart (experimental group) and without the patient education chart (control group) for 4 weeks.
Read the detailed description
The prevalence of stroke in adults increased by 14.6% in 2022 compared to data collected in 2013. Poor balance, postural asymmetry, abnormal gait, and fall-related complications due to reduced trunk control can limit social interactions. Trunk control is an important predictor of functional independence for stroke-affected individuals recovering from functional impairments. Studies have found that individuals with post-stroke hemiparesis have mild-to-severe trunk dysfunction even 6 months post-stroke occurrence. Evidence also indicates that the muscular strength of the trunk is significantly reduced in acute and chronic stages, which leads to poor functional performance. As trunk function significantly contributes to functional recovery, the importance of trunk training needs to be emphasized, and education should be provided to stroke patients for faster functional mobility.
Patient education programs guide patients, caregivers, and family members to understand and promote the patient's participation in continuing care and treatment decisions. This method assists patients in incorporating information, expertise, beliefs, and behaviors related to their health promotion and faster functional recovery from physical and psychological impairments. Patient education provides adequate and appropriate scientific knowledge for patients to improve their awareness of illness conditions and health-promoting practices. Studies also suggest that the patient education process increases patient's involvement in rehabilitation practices.
Although trunk control exercises are performed during routine rehabilitation programs, knowledge and education about trunk training exercises are not specifically emphasized in stroke rehabilitation protocols. Stroke patients need to be educated not only about upper and lower functional training but also should understand trunk control training during their rehabilitation process to acquire skills.
In this proposed study, a patient education program highlighting the significance of trunk control, its role in functional improvement, and patient-centered self-care might provide better functional mobility compared to a standalone trunk control exercises program. Through this program, patients can concentrate not only on limb training but also emphasize trunk-related functional tasks to improve overall body function. Therefore, our current study hypothesized that a patient education program about the trunk training program during the rehabilitation process may improve balance and functional mobility better than a standalone trunk control exercises program in patients with post-stroke hemiparesis.
- Conditions
- Strokes Thrombotic
- Being tested
- Trunk control exercises combined with patient education program, Trunk control exercises
- Keywords
- Stroke, Hemiparesis, Trunk control, Patient education, Balance
- Medical subject headings
- Thrombotic Stroke, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk control exercises combined with patient education programDevice
Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces. In addition, the experimental group provided a patient education program which focuses on the importance of trunk control and benefits of trunk control exercises during the rehabilitation process. Further, caregivers and family members were also explained about the patient education program and adherence with treatment protocol during and after the interventions.
Trunk control exercisesDevice
Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Trunk control exercises with Patient education program | Experimental | This group have received Trunk control exercises along with patient education program. Receives: Device: Trunk control exercises combined with patient education program |
| Trunk control exercises | Active comparator | This group have received standalone trunk control exercises. Receives: Device: Trunk control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk impairment scale
The Trunk Impairment Scale (TIS) is a valid tool for assessing motor impairment of the trunk in stroke patients. In a sitting position, patient's static and dynamic sitting balance, as well as trunk coordination were assessed. For the static subscale, the patient's ability to maintain a sitting position with feet supported and legs crossed. The lateral flexion of the trunk and unilateral hip lifting were assessed to quantify the dynamic sitting balance. To assess the coordination function, the patient was instructed to rotate the upper or lower part of their trunk six times, initiating movements from the shoulder or pelvic girdle. The total score ranges from 0 (minimal performance) to 23 (perfect performance). This scale has high reliability, validity, and predictive value for functional outcomes, making it an effective tool for evaluating trunk function in stroke patients
Measured: Baseline, post-treatment week 4
Secondary outcomes (2)
Functional Mobility
The Rivermead Mobility Index (RMI) is a valid tool for assessing functional mobility in stroke patients. It is the 15-item questionnaire, which includes 14 self-reported items and one direct observation task. The items cover a range of mobility activities, from turning in bed to running. For each item, the patient receives a score of 1 if they can perform the task independently, or 0 if they cannot. The assessor allowed the patient to attempt each task unless there is a safety concern. The total score ranges from 0 to 15, with higher scores indicating better functional mobility
Measured: Baseline, post-treatment week 4
Berg Balance Scale
The Berg Balance Scale (BBS) is a valid and reliable tool, consisting of 14-items that evaluates a patient's ability to maintain balance while performing functional tasks. The assessment items range from simple activities like sitting unsupported to more challenging tasks such as standing on one foot. Each item is scored on a 5-point ordinal scale from 0 (unable to perform) to 4 (independent) depending on the patient's achievement level. A score of ≤49/56 indicates a fall risk in stroke patients and change of 4-7 points considered clinically significant improvement
Measured: Baseline, post-treatment week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start15 Dec 2020
- Primary completion25 Sep 2021
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strokes ThromboticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramprasad Muthukrishnan, PDF, Study chair, Gulf Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679699
- Sponsor's protocol ID
- IRB-COHS-STD-09-DEC-2020
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data may be provided based upon request related to research purpose
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Patient Education Program About Trunk Control Exercises on Balance and Functional Mobility in Individuals With Post-stroke Hemiparesis: A Randomized Control Trial"
- ClinicalTrials.gov ID
- NCT06679699
- Acronym / sponsor ID
- IRB-COHS-STD-09-DEC-2020
- Conditions
- Strokes Thrombotic
- Keywords
- Stroke, Hemiparesis, Trunk control, Patient education, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 7 Nov 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.
The trunk movement awareness and education of individuals with post-stroke hemiparesis is not emphasized adequately in clinical practice. Therefore, this current study was made to hypothesize whether a patient education program about dynamic trunk control exercises during stroke rehabilitation may influence trunk control. 40 individuals with post-stroke hemiparesis were recruited and randomly allocated to the experimental and control group. Both the groups received 1 hour of exercises focusing more on dynamic trunk control exercises with patient education chart (experimental group) and without the patient education chart (control group) for 4 weeks.
Detailed description
The prevalence of stroke in adults increased by 14.6% in 2022 compared to data collected in 2013. Poor balance, postural asymmetry, abnormal gait, and fall-related complications due to reduced trunk control can limit social interactions. Trunk control is an important predictor of functional independence for stroke-affected individuals recovering from functional impairments. Studies have found that individuals with post-stroke hemiparesis have mild-to-severe trunk dysfunction even 6 months post-stroke occurrence. Evidence also indicates that the muscular strength of the trunk is significantly reduced in acute and chronic stages, which leads to poor functional performance. As trunk function significantly contributes to functional recovery, the importance of trunk training needs to be emphasized, and education should be provided to stroke patients for faster functional mobility.
Patient education programs guide patients, caregivers, and family members to understand and promote the patient's participation in continuing care and treatment decisions. This method assists patients in incorporating information, expertise, beliefs, and behaviors related to their health promotion and faster functional recovery from physical and psychological impairments. Patient education provides adequate and appropriate scientific knowledge for patients to improve their awareness of illness conditions and health-promoting practices. Studies also suggest that the patient education process increases patient's involvement in rehabilitation practices.
Although trunk control exercises are performed during routine rehabilitation programs, knowledge and education about trunk training exercises are not specifically emphasized in stroke rehabilitation protocols. Stroke patients need to be educated not only about upper and lower functional training but also should understand trunk control training during their rehabilitation process to acquire skills.
In this proposed study, a patient education program highlighting the significance of trunk control, its role in functional improvement, and patient-centered self-care might provide better functional mobility compared to a standalone trunk control exercises program. Through this program, patients can concentrate not only on limb training but also emphasize trunk-related functional tasks to improve overall body function. Therefore, our current study hypothesized that a patient education program about the trunk training program during the rehabilitation process may improve balance and functional mobility better than a standalone trunk control exercises program in patients with post-stroke hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Trunk control exercises with Patient education program | Experimental | Device: Trunk control exercises combined with patient education programThis group have received Trunk control exercises along with patient education program. |
| Trunk control exercises | Active comparator | Device: Trunk control exercisesThis group have received standalone trunk control exercises. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with ischemic stroke
- Grade 1 - 2 Spasticity
- Hemiparesis
Key exclusion criteria (6 listed)
- Moderate to severe cognitive deficits,
- Alzheimer's disease,
- Language difficulties,
- Unstable blood pressure
- Uncontrolled epilepsy,
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 |
|---|---|---|
| Trunk control exercises combined with patient education programPatients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces. In addition, the experimental group provided a patient education program which focuses on the importance of trunk control and benefits of trunk control exercises during the rehabilitation process. Further, caregivers and family members were also explained about the patient education program and adherence with treatment protocol during and after the interventions. | Device | Trunk control exercises with Patient education program |
| Trunk control exercisesPatients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces. | Device | Trunk control exercises |
Primary outcome
Trunk impairment scale
Time frame: Baseline, post-treatment week 4
The Trunk Impairment Scale (TIS) is a valid tool for assessing motor impairment of the trunk in stroke patients. In a sitting position, patient's static and dynamic sitting balance, as well as trunk coordination were assessed. For the static subscale, the patient's ability to maintain a sitting position with feet supported and legs crossed. The lateral flexion of the trunk and unilateral hip lifting were assessed to quantify the dynamic sitting balance. To assess the coordination function, the patient was instructed to rotate the upper or lower part of their trunk six times, initiating movements from the shoulder or pelvic girdle. The total score ranges from 0 (minimal performance) to 23 (perfect performance). This scale has high reliability, validity, and predictive value for functional outcomes, making it an effective tool for evaluating trunk function in stroke patients
2 secondary outcomes
Functional Mobility
Time frame: Baseline, post-treatment week 4
Berg Balance Scale
Time frame: Baseline, post-treatment week 4
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 8 Nov 2024.
- Individual participant dataSharing planned: No. The data may be provided based upon request related to research purpose
Related trials for Strokes Thrombotic
RecruitingObservational study
Baby Brain Recovery Study
Perinatal Stroke
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
Not yet recruitingPhase 3
Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy
Stroke, Acute Ischemic Stroke
RecruitingPhase 4
Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
Lacunar Stroke, Stroke
Not yet recruitingObservational study
Master Study Protocol for the Cohort of the Specialist Network Stroke (SN Stroke)(Stroke-CORE)
Intracerebral Haemorrhage, Paediatric Stroke
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.
Ramprasad Muthukrishnan, PDF study chair
Gulf Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Strokes Thrombotic, run by Gulf Medical University at 1 site in United Arab Emirates.
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 3 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: finished, as of the sponsor's last update on 8 Nov 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 United Arab Emirates. 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?
Trunk impairment scale (time frame: Baseline, post-treatment week 4). 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 Nov 2024.