NCT05510258

Brief Summary

This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of p valued 0.05. Results were in the favour of experimental group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

January 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 15, 2022

Last Update Submit

August 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Berg balance scale at week 4

    Berg balance scale(BBS) used clinical test of a person's static and dynamic balance abilities. BBS comprises a set of 14 items which includes unsupported sitting to unsupported standing and weight shifting while standing unsupported. * Lower score =1 (Sitting to standing) * Higher score=14 (weight shifting while standing)

    Baseline and 4 weeks

  • Change from baseline in Trunk impairment scale at week 4

    The Trunk Impairment Scale (TIS) is a tool to measure motor impairment of the trunk after stroke. TIS scores on a range from 0 to 23. Static sitting balance, Dynamic sitting balance and Co-ordination will be evaluated by this scale. * Static sitting balance=7 * Dynamic sitting balance=10 * Co-ordination=6

    Baseline and 4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

core-stability exercises therapy given with conventional therapy

Other: Physiotherapy

control group

OTHER

only conventional therapy given

Other: Physiotherapy

Interventions

TWO GROUPS CONTROL ND EXPERIMENTAL

control groupexperimental group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sub-Acute ischemic and stroke diagnosed by neuro-physican having 1st episode
  • Patients in sub-acute stage (2-12 weeks)
  • Patients who can follow the instruction according to mini mental scale \< 7
  • Minimum score of a patient on burg balance and trunk impairment scale to enter in rehab unit and include in any research i-e TIS \< 2 in scoring and BBS \< 4 minimum scoring.

You may not qualify if:

  • Recurrent stroke
  • Subjects with radiating pain or nerve root involvement
  • Diagnosed by any neurological condition other than stroke, or other clinical comorbidity that affect the trunk balance.
  • Patient unable to follow the instructions
  • Comprehension deficits that prevented them from following verbal commands
  • Unconscious patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duaa Awais

Lahore, Punjab Province, 53700, Pakistan

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Rabbani Hospital

    PMDC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two groups control and experimental included
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 22, 2022

Study Start

January 7, 2020

Primary Completion

March 2, 2020

Study Completion

March 5, 2021

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations