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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06181877
Other study ID # ELMTRAMABHP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date October 31, 2023

Study information

Verified date December 2023
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with post-stroke hemiplegia may develop balance disorder and limitation in ambulation ability due to multiple mechanisms. The effects of core muscles on maintaining normal posture, balance and ambulation ability are known. The positive effects of core stabilisation exercises on balance in hemiplegic patients have been shown in previous studies. In this study, we planned to investigate the effects of bilateral transversus abdominis and bilateral lumbar multifidus muscles on balance in patients with stroke-related hemiplegia.


Description:

Loss of function in the trunk muscles of stroke patients leads to both balance problems and excessive effort to maintain balance. While ambulation ability of some patients is completely lost due to stroke, in others, impaired balance and increased postural oscillation lead to fear of falling and increased risk of falling. In previous studies, it has been shown that there is a significant relationship between static balance and duration of hospital stay and functional abilities after stroke. In another study, it was shown that the control ability of the trunk muscles in the early post-stroke period was a strong factor affecting general life activities in the first six months after stroke. Trunk muscles are innervated by both hemispheres unlike the extremities. Therefore, unilateral stroke may impair the function of trunk muscles on both the contralateral and ipsilateral sides. Several studies have shown dysfunction of bilateral trunk flexor, extensor and rotator muscles in patients with unilateral stroke. Many studies have proven that core stabilisation exercises are effective on both balance and gait function and general life activities in hemiplegic patients. The aim of this cross-sectional study was to investigate the effect of ultrasound-guided bilateral transversus abdominis and bilateral lumbar multifidus muscle activations on balance in hemiplegic patients.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 31, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients aged 18-65 years - Time after stroke must be at least 1 month - Unilateral stroke - Must be cognitively compatible in terms of cooperation - Standing balance with/without support and/or sitting balance without support - BMI<30 Exclusion Criteria: - Patients with a history of hemiplegia in the opposite half of the body - Patients with extruded or sequestered lumbar hernia and/or history of lumbar operation - Patients with a history of lumbar vertebral fracture - Patients with traumatic brain injury - Patients with neuromuscular muscle disease that may lead to muscle atrophy - Patients with sensory defects - Patients with cerebellar defects - Patients with vestibular balance disorders (vertigo, etc.) - Patients with Parkinson's disease - Patients with balance problems due to visual impairment - Patients with pre-stroke balance problems

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training & Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Berg Balance Scale (BBS) Patients' balance was evaluated using the Berg Balance Scale. Same day with ultrasound-guided muscle measurement
Primary Postural Assessment Scale For Stroke Patients (PASS) Posture change and posture maintenance scores of the patients were evaluated using PASS. Same day with ultrasound-guided muscle measurement
Primary Functional Ambulation Category (FAC) Ambulation ability of the patients was evaluated using FAC. Same day with ultrasound-guided muscle measurement
Secondary Brunnstrom Stages Limb function of the patients was evaluated using Brunnstrom Staging. Same day with ultrasound-guided muscle measurement
Secondary Transversus Abdominis Muscle Activation [(transversus abdominis contraction thickness)-(transversus abdominis resting thickness)]/transversus abdominis resting thickness BBS, PASS, FAC and Brunnstrom stages were measured immediately after recording.
Secondary Multifidus Muscle Activation [(multifidus contraction thickness)-(multifidus resting thickness)]/multifidus resting thickness BBS, PASS, FAC and Brunnstrom stages were measured immediately after recording.
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