Patient Education Program and Trunk Control Exercises in Post-stroke

NCT06679699 | Completed DMC

• 1 other identifier: IRB-COHS-STD-09-DEC-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Strokes Thrombotic

Keywords

Stroke; Hemiparesis; Trunk control; Patient education; Balance

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, post-treatment week 4

Secondary Outcomes (2)

• Functional Mobility

  Baseline, post-treatment week 4

• Berg Balance Scale

  Baseline, post-treatment week 4

Study Arms (2)

Trunk control exercises with Patient education program

EXPERIMENTAL

This group have received Trunk control exercises along with patient education program.

Device: Trunk control exercises combined with patient education program

Trunk control exercises

ACTIVE COMPARATOR

This group have received standalone trunk control exercises.

Device: Trunk control exercises

Interventions

Trunk control exercises combined with patient education program DEVICE

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 exercises with Patient education program

Trunk control exercises DEVICE

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.

Trunk control exercises

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ischemic stroke
• Grade 1 - 2 Spasticity
• Hemiparesis

You may not qualify if:

• Moderate to severe cognitive deficits,
• Alzheimer's disease,
• Language difficulties,
• Unstable blood pressure
• Uncontrolled epilepsy,
• Dislocations/fractures

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, 4184, United Arab Emirates

Location

MeSH Terms

Conditions

Thrombotic Stroke; Stroke; Paresis

Condition Hierarchy (Ancestors)

Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramprasad Muthukrishnan, PDF

  Gulf Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor was blinded to the participants allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: December 15, 2020
• Primary Completion: September 25, 2021
• Study Completion: October 16, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)