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Recruiting NCT07576166

Combined Effects of Rhythmic Breathing and Balance Training on Balance and Trunk Control in Stroke Patients

No phase Interventional Sub-acute Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rhythmic breathing exercise, Balance training, conventional physical therapy.
Who it may be relevant to
Registry conditions: Sub-acute Stroke. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Combined Effects of Rhythmic Breathing Exercises and Balance Training on Balance and Trunk Control in Patients With Stroke

Overview

The goal of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in patients with sub-acute stroke. The main questions it aims to answer are: * Will there be a difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke? * Will there be no difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke? The participants will be evenly divided into two groups, * the experimental group will receive rhythmic breathing exercises along with balance training and conventional physical therapy * the control group will only receive balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes, 3 days a week for consecutive 8 weeks.

Detailed description

The aim of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in sub-acute stroke patients. It will be a single blinded randomized controlled trial. Non-probability convenience sampling will be used to recruit 50 patients aged 45-65 years from Dr. Faisal Masood Teaching Hospital Sargodha. Through the computerized generator table method of randomization, the allocated patients will be evenly divided into two groups, the experimental group undergoing Rhythmic Breathing exercises along with Balance training and conventional physical therapy and the control group only balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes 3 days a week for consecutive 8 weeks. The stroke patients will be assessed at the baseline and post intervention with outcome measuring tools. Balance will be assessed through Berg Balance Scale (BBS), trunk control will be assessed through Trunk Impairment Scale(TIS), and postural control will be assessed through Postural Assessment Scale for Stroke (PASS). Data will be analyzed in SPSS version 27.0.

Interventions

  • Other rhythmic breathing exercise
    The protocol for Rhythmic Breathing Exercises (22) is given as: Position: Supine with knees and hips slightly flexed, in a comfortable position Inhalation Phase: Deep inhalation with conscious outward movement of the abdomen; pause and hold for 10 seconds Exhalation Phase: Slow exhalation with conscious abdominal retraction, maintaining a slow and deep rhythm Hand Placement: One hand on the chest, one on the abdomen to monitor movement Breathing Cue: Only the hand on the abdomen should move dur
  • Other Balance training
    Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg ste
  • Other conventional physical therapy
    Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week

Primary outcome measures

  • Berg Balance Scale [Time frame: Baseline and 8th week]
  • Trunk Impairment Scale [Time frame: Baseline and 8th week]
  • Postural Assessment Scale for Stroke [Time frame: Baseline and 8th week]

Eligibility criteria

Inclusion criteria

  • Age 45-65 years old
  • Either gender
  • Sub-acute stroke (3-6months)
  • The cognition level of patient according to Mini Mental Score Examination will be >24
  • The trunk control of patient based on Trunk Impairment score is 20 or less than 23
  • First-ever ischemic stroke
  • Ability to tolerate at least 60 min exercise according to berg scale scoring less than 8
  • Agree to sign the written informed consents

Exclusion criteria

  • • Severe visual hemianopsia
  • Acute diseases of the heart, brain, kidney and other organs
  • Sensory neuropathy such as diabetic neuropathy
  • Balance dysfunction due to other neurological disorders

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Dr. Faisal Masood Teaching Hospital Sargodha — Sargodha

Identifiers

NCT: NCT07576166 · REC/RCR & AHS/25/0233

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗