NCT05491863

Brief Summary

Rationale of this research is to evaluate the outcome of trunk stabilizing exercises on the fine motor skills of subjects with hemiplegic CP. The significance of this study is to identify how much core stability exercises improve hand function. This study will help gather evidence on the practice of core stabilizing exercises to improve hand function so that it can help both physicians and patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

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

October 28, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
Last Updated

August 8, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 24, 2022

Last Update Submit

August 4, 2022

Conditions

Keywords

trunk stabilityhand function

Outcome Measures

Primary Outcomes (3)

  • Trunk Control Meaurment Scale

    The trunk control measurement scale measures two mechanism of trunk control throughout functional activities. First level begins with smooth base of support and it ends on dynamic service to assess balance of body.15 items performed with the sub scales that consist of 5, 7 and 3 activities respectively. Total score ranges from 0 to 58 on scale.

    12 week

  • ABILHAND-kids (Manual Ability Measure)

    ABILHAND-Kids questionnaire is valuable tool to assess a child's unimanual and bimanual upper limb activities. This 21 items hand use scale with total 63 score prestents low to high performance of fine motor .

    12 week

  • CHEQ (Children's hand-use experience's questionnaire)

    Children's Hand-use Experience Questionnaire has been developed to capture kid's perceived quality of performance when using the affected hand in these situations. CHEQ is an internet based questionnaire containing 29 items with (bimanual activities) presented one by one in random order .score ranges from 0 to 100 representing better function with higher score .

    12 weeks

Secondary Outcomes (3)

  • UE MAL

    12 weeks

  • Manual ability classification system

    12 weeks

  • Modified ash worth scale (MAS)

    12 weeks

Study Arms (2)

conservative physiotherapy plan

ACTIVE COMPARATOR

Postural and Proprioceptive facilitation,walking ,jumping and staircase activity

Other: conservative physiotherapy planOther: trunk stability exercise plan

Trunk stability exercise plan

EXPERIMENTAL

Trunk stability exercises including proprioception,balance and stability.

Other: conservative physiotherapy planOther: trunk stability exercise plan

Interventions

Physiotherapy plan consist of following exercises, Postural and Proprioceptive facilitation like weight-bearing actions for the upper and lower extremities. Sit to stand, standing , holding on to stand, free arms standing up, holding on standing and asked the patient to lift one leg, one leg standing, standing on balance board,Straight and sideways parallel bar walk, For the effected body side jumping on stable and dynamic surface,Upstairs and down stair activity performed on staircase.This program was given for 40 minutes with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions)

Trunk stability exercise planconservative physiotherapy plan

trunk stability exercise plan consist of three levels, Proprioception included supine abdominal draw was performed in 1st simple level ,3 sets per 20 repetitions were performed, A double knee to chest abdominal draw was performed with 3 sets per 20 repetition, Supine twist with 3 sets per 20 repetitions was performed.Balance training included pelvic bridging was 2nd complicated level performed with 3 sets per 4-6 repetitions,Twists with a medicine ball were performed with 3 sets per 10-20 repetitions. for Stability Bridging with head lied on physio ball was performed in 3rd difficult level when holding the position for 4 to 6 seconds, then relaxed slowly for same time with 3 sets per 10 to 20 repetitions, Prone bridging was performed with 3 sets per 4 to 6 repetitions. There was a 30 seconds to 1 minute break between the sets.This program was given for 1 hour with a rest period of 2 minutes between each group of exercises, 4 days a week for 8 weeks (32 sessions)

Trunk stability exercise planconservative physiotherapy plan

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both male and female were included
  • Age group 6 to 18 years.
  • Medical diagnosis of hemiplegic cerebral palsy assured.
  • Unilateral Movement deficit (less than 2.5) on amount of use scale on MAL (motor activity log).
  • Level 1 to 3 on manual ability classification system (MACS).
  • Mild to moderate spasticity of upper extremity (MAS grade 1 to 2.)
  • GMCS level I-II.
  • Subjects were cognitively capable and competent to follow the instructions

You may not qualify if:

  • Patients with altered conscious level.
  • Previous surgery or pain in upper limbs.
  • Rigid contracture and fixed deformities in the spine
  • Auditory / vision problem.
  • Previous Botulinum Toxin-A injections in upper limb.
  • Cardio-respiratory problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising sun institute for special children

Lahore, Punjab Province, 54792, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sidra Shafique, tDPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researchers who evaluated the participants were not informed of how the participants were grouped. Participants were informed that they would receive one of two different interventions without indicating which group should undergo trunk stability or conventional physiotherapy program.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: . Participants were randomly assigned to the experimental group or control group after a baseline assessment with a lottery ticket and an opaque envelope containing the same number of folded papers labeled "control" or "intervention." Each participant took a piece of paper that identified their group and gave it to the researchers without seeing what was written. Participants were not notified which group was assigned to
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

August 8, 2022

Study Start

October 28, 2021

Primary Completion

February 25, 2022

Study Completion

May 25, 2022

Last Updated

August 8, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations