NCT03053154

Brief Summary

The purpose of this study is to assess and determine the influence of pelvic inclination on sit to stand task in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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

September 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 14, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

January 22, 2017

Last Update Submit

May 11, 2017

Conditions

Keywords

Pelvic InclinationSit to StandStrokeAnterior pelvic tiltPosterior pelvic tilt

Outcome Measures

Primary Outcomes (1)

  • posterior pelvic tilt angle

    Posterior pelvic tilt angle measured by the palpation meter (PALM) inclinometer. It was assessed as one shot in one assessment session.

    One shot (Each participant was assessed immediately and it takes about 15 minutes)

Secondary Outcomes (1)

  • Pelvic Inclination analysis in sit to stand task

    One shot (Each participant is assessed immediately and it takes about 10 minutes)

Study Arms (3)

Experimental group1

15 stroke patients with right side affection, their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.

Other: Sagittal pelvic tilt assessment

Experimental group2

15 stroke patients with left side affection, their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.

Other: Sagittal pelvic tilt assessment

Control group

15 Normal subjects without any diseases or dysfunctions , their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.

Other: Sagittal pelvic tilt assessment

Interventions

Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.

Control groupExperimental group1Experimental group2

Eligibility Criteria

Age45 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The patients were recruited from the Out-patient clinic for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University and Out- patient clinic of El-kasr El-Aini Hospital, Faculty of Medicine, Cairo University

You may qualify if:

  • Patients' age ranged from 45-60 years old.
  • Normal body weight with a body mass index (BMI) ranged from 18.5 to 24.9 kg/m2.
  • Patients' had the ability to maintain sitting position without using any aids.
  • Patients' had the ability to stand from sitting five times independently.
  • Cooperative patients with ability to understand instructions and follow simple verbal commands.
  • The duration of illness was from six months to 2 years.
  • The degree of the paretic lower limb spasticity ranged between (1:1+) according to the Modified Ashworth Scale.
  • The degree of the paretic lower limb weakness was not less than grade 3 according to group muscle testing.

You may not qualify if:

  • History of previous strokes and other neurological disorders.
  • Visual, auditory and vestibular deficits.
  • Cognitive impairments and language deficits.
  • Leg length discrepancy is more than 0.5 cm.
  • Previous history of orthopedic conditions in back or lower limbs (e.g. low back pain, fractures, deformities and surgeries).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manar El-sayed Ismail

Giza, 12211, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Manar El-sayed Ismail

    Cairo University

  • Moshera H. Darwesh, Professor

    Cairo University

  • Sandra M. Ahmed, Assistant Professor

    Cairo University

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2017

First Posted

February 14, 2017

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Locations