NCT06067724

Brief Summary

The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
recruiting

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

May 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

September 28, 2023

Last Update Submit

April 5, 2024

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Biodex System 3 Pro Isokinetic

    Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention

    Six weeks after the beginning of the intervention

Secondary Outcomes (3)

  • Fugl-Meyer Assessment for upper extremity

    Six weeks after the beginning of the intervention

  • Box and block test

    Six weeks after the beginning of the intervention

  • Hand grip dynamometer

    Six weeks after the beginning of the intervention

Study Arms (2)

Pelvic and trunk control exercises

ACTIVE COMPARATOR

Twenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program.

Other: Pelvic and trunk control exercises

Traditional physical therapy

SHAM COMPARATOR

Twenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks.

Other: Pelvic and trunk control exercises

Interventions

Pelvic and trunk control exercisesOTHER

Patients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic and trunk control exercises for 40 min included abdominal drawing in maneuver for contraction of transversus abdominis pelvic tilting exercises and pelvic stabilization exercises from different positions. Pelvic tilting exercises included; anterior, posterior, lateral pelvic tilting and pelvic rotation on a therapeutic ball. Pelvic stabilization exercises include bridging, half bridging, clamshell from supine and side lying, quadribed exercises, weight shifting on the affected limb from standing by forward and diagonal reach out, ball bridging and rhythmic stabilization exercises

Pelvic and trunk control exercisesTraditional physical therapy

Eligibility Criteria

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

You may qualify if:

  • Patient's age will range from 45 - 60 years.
  • Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale.
  • Duration of illness will range from 6 to 18 months after stroke onset.
  • Ability of the patient to stand without assistive devices.

You may not qualify if:

  • Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy.
  • Severe chronic back and/or knee pain that might affected standing posture.
  • Recurrent stroke
  • Shoulder or upper limb injury that might affect the recovery.
  • Perceptual or cognitive dysfunctions.
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of physical therapy labs at Cairo University

Giza, 12612, Egypt

RECRUITING

Faculty of physical therapy labs at Cairo University

Giza, 12612, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Rowida Abdelgleel, Assistant lecturer

CONTACT

01152322678rowidaabdelglel@gmail.com

Nahed Salem, Professor

CONTACT

+201224297063nahedsalem960@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

May 20, 2023

Primary Completion

April 1, 2024

Study Completion

April 7, 2024

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations

EG(2)