NCT07576166

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jul 2026

First Submitted

Initial submission to the registry

May 4, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 5, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Rhythmic breathing exercisesBalance trainingBerg balance scaleStroke

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale

    The BBS is a 14-item measure used to assess functional mobility, static balance, and dynamic balance excluding ambulation. However, BBS scores have also been correlated with stroke patient's motor and functional performance. Scores range on an ordinal scale from zero (indicating need for assistance to minimally perform the task) to four (indicating independent performance of the task); with a maximum possible score of 56. Historically, a score below 45/56 is typically indicative of increased fall risk.

    Baseline and 8th week

  • Trunk Impairment Scale

    The original version of Trunk Impairment Scale (TIS) was developed by in 2004. It comprises 17 items (scored on a 2, 3 or 4-point ordinal scale) and evaluates static and dynamic sitting, balance and trunk coordination. The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance.

    Baseline and 8th week

  • Postural Assessment Scale for Stroke

    The Postural Assessment Scale for Stroke (PASS) is a scale developed specifically for stroke patients. It examines the patient's ability to maintain or change a given lying, sitting or standing posture, is easy to administer in the clinic and applicable to all patients, even those with very poor postural performance. It contains 12 items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The items are assessed on a 4 level (0-3 point) rating scale. The score ranges from a minimum of 0 (worst performance) to a maximum of 36 (best performance).

    Baseline and 8th week

Study Arms (2)

Rhythmic breathing exercises

EXPERIMENTAL
Other: rhythmic breathing exerciseOther: Balance trainingOther: conventional physical therapy

Balance training and conventional physical therapy

ACTIVE COMPARATOR
Other: Balance trainingOther: conventional physical therapy

Interventions

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 during breathing; the chest should remain still Repetitions: 3 sets of 10 repetitions Rest Between Sets: 1 minute Total Duration: Limited to 10 minutes

Also known as: Balance training, conventional physical therapy
Rhythmic breathing exercises

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 stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions

Balance training and conventional physical therapyRhythmic breathing exercises

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 for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes

Balance training and conventional physical therapyRhythmic breathing exercises

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Faisal Masood Teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hira Jabeen

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

May 5, 2026

Primary Completion (Estimated)

July 5, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations