NCT05915195

Brief Summary

The goal of this randomized controlled trial is to check the effects of postural and kinesthetic awareness on static standing balance in chronic stoke patients. Participants will be divided into two equal groups. One group will receive routine physical therapy while other group will receive postural and kinesthetic awareness in addition to routine physical therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

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

December 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

April 14, 2023

Last Update Submit

December 3, 2023

Conditions

Keywords

strokestatic balanceplantar pressurepostural and kinestetic awarenessPoData Stabiliometeric plate

Outcome Measures

Primary Outcomes (2)

  • Static Component of Berg Balance Scale

    Static component of Berg Balance Scale was used to measure static standing balance. Total score of berg balance scale is 56. A score of 56 indicates functional balance.A score of \< 45 indicates individuals may be at greater risk of falling.

    6 months

  • PoData Stabiliometric Plate

    PoData stabiliometric plate was used for the static plantar pressure evaluation. It recorded statistics of plantar pressure.

    6 months

Study Arms (2)

Routine Physical Therapy

ACTIVE COMPARATOR

routine physical therapy including range of motion exercises (Active assisted), stretching exercises, strengthening and positioning. Daily session was of 1 hour, 5 times weekly for 6 weeks.

Other: Routine Physical Therapy

Routine Physical Therapy and Postural and Kinesthetic Awareness

EXPERIMENTAL

routine physical therapy and additionally postural and kinesthetic Awareness in front of mirror by emphasizing proper body positioning, movements \& balance in sitting and standing position by using interoceptive and exteroceptive reinforcement (verbal, tactile \& visual).

Other: Postural and Kinesthetic Awarness

Interventions

Firstly, patient performed therapeutic activities/exercise to achieve balance in sitting position using chair with arm rest and with planted feet then progressed to sitting on chair without arm rest with proper feet placement. Once the patient achieved balance in sitting on chair then shifted to sitting on the stool and later standing in parallel bar that leads to balance training in independent standing.

Also known as: Experimental Group
Routine Physical Therapy and Postural and Kinesthetic Awareness

Range of motion exercises (Active assisted), stretching exercises, strengthening and positioning.

Also known as: Control Group
Routine Physical Therapy

Eligibility Criteria

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

You may qualify if:

  • Chronic stroke patient
  • Both genders
  • Age: 45-60 years
  • score or higher on static part of Berg Balance Scale
  • Level 1 and 2 of Modified Ashworth Scale
  • or more score on Mini mental state scale

You may not qualify if:

  • Patients with
  • Psychological diseases
  • Dementia
  • Orthopedic disorders
  • Any insufficiency that can influence balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Rauf W, Sarmad S, Liaqat S, Saleem S, Jawad M, Ahad M. Effects of postural and kinesthetic awareness on static standing balance and plantar pressure in chronic stroke: a randomized controlled trial. J Pak Med Assoc. 2024 Oct;74(10):1755-1760. doi: 10.47391/JPMA.10538.

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sameed Liaquat, 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
Prinicipal Investigator

Study Record Dates

First Submitted

April 14, 2023

First Posted

June 22, 2023

Study Start

December 20, 2022

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations