NCT05436782

Brief Summary

To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 3, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

June 23, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

Stroke, Static Balance, PNF, Plantar Pressure, PoData

Outcome Measures

Primary Outcomes (1)

  • Static Standing balance

    It is measured 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 and a score of 4 representing independent item completion. Static component score is calculated out of 24 possible points. Scores of 0 to 9 represent static balance impairment, 10 to 15 represent acceptable static balance, and 15 to 24 represent good static balance

    6 months

Secondary Outcomes (1)

  • Plantar pressure

    6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

• Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises will be pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session will be of 60 minutes 5 times weekly for 6 weeks

Other: Routine physical therapy

Group B

EXPERIMENTAL

Group B (experimental group) will receive routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals will be 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. The outcome measure will be measured at and 6th week interval

Other: core strengthening exercises

Interventions

•Group B (experimental group) received routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in the lower extremity in D1 flexion pattern and D1 extension pattern up to the patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks. The outcome measure was measured at baseline and 6th-week interval

Group B

•Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks

Group A

Eligibility Criteria

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

You may qualify if:

  • Age 45-60
  • Score of 9 or higher on the static component of Berg Balance Scale
  • Both genders will be recruited.
  • First ever episode of stroke
  • Duration of stroke greater than 6 months.
  • Having a score of equal to or less than 2 on the Modified Ashworth Scale
  • Having a score of greater than or equal to 24 on the Mini-mental state examination in order to understand the commands.

You may not qualify if:

  • Concurrent orthopedic (for e.g. amputation ) that may hamper standing
  • Relevant psychiatric disorders that may prevent from following instructions.
  • Other medical drugs that may influence our intervention
  • Condition contraindicating physical activity
  • Use of cardiac pacemakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjqb, 40050, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sameed Liaqat, DPT

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameed Liaqat, DPT

CONTACT

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
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

December 3, 2021

Primary Completion

June 30, 2022

Study Completion

August 14, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations