NCT06346652

Brief Summary

Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study. This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

March 21, 2024

Last Update Submit

July 20, 2024

Conditions

Keywords

core strengtheningplantar pressure

Outcome Measures

Primary Outcomes (1)

  • Static Standing Balance

    Measure using static component of berg balance scale. The items are scored from 0 to 4 with a score of 0 representing an inability to complete the task. Score of 4 representing independent item completion.

    6 weeks

Secondary Outcomes (1)

  • Plantar Pressure

    6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Routine Physical Therapy

Other: Routine Physical Therapy

Interventional Group

EXPERIMENTAL

Routine Physical Therapy + PNF + Core Strengthening

Other: Routine Physical Therapy+ PNF and Core Stregthening

Interventions

Routine physical therapy involving muscle strengthening exercises, range of motion exercises and stretching exercises up to patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks.

Control Group

Routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in lower extremity in D1 flexion pattern and D1 extension pattern up to patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks.

Interventional Group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age (45-60 years)
  • Score of 9 or Higher on static component of berg balance scale
  • Having score of equal or less than 2 on Modified Ashworth scale
  • Having score of greater than or equal to 24 on Mini Mental State Examination.
  • First ever episode of stroke
  • Duration of stroke greater than 6 months
  • Both genders

You may not qualify if:

  • Concurrent orthopedic conditions that may hamper standing
  • Relevant psychiatric disorders that may prevent from following instructions.
  • Medical drugs that may influence intervention
  • Conditions contraindicating physical activity
  • Use of Cardiac pace maker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54000, Pakistan

Location

Study Officials

  • Safa Saleem, MSPTN

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Safa Saleem

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 4, 2024

Study Start

March 10, 2024

Primary Completion

April 22, 2024

Study Completion

April 30, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations