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Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conservative physiotherapy plan
trunk stability exercise plan
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring trunk stability, hand function

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rising sun institute for special children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conservative physiotherapy plan

Trunk stability exercise plan

Arm Description

Postural and Proprioceptive facilitation,walking ,jumping and staircase activity

Trunk stability exercises including proprioception,balance and stability.

Outcomes

Primary Outcome Measures

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.
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 .
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 .

Secondary Outcome Measures

UE MAL
It consists of both the AS and HW scales are used during all test administrations, except for the periodic administrations of MAL during treatment, when only the HW scale is used. In all administrations except those done during treatment, begin with AS scale and ask participants to rate all task using the AS scale first the participant than rates all tasks perform with the HW scale
Manual ability classification system
It's a 5 level ordinal classification system which describes the manual ability of children aged 4 to 18 years with cerebral palsy. When children holds objects in typical activities, MACS levels describe the collaborative use of both hands together in daily life activities .As a classification system the purpose of MACS is to discriminate meaningfully on child's manual ability to handle objects in daily living. It's not an outcome measure or diagnostic tool
Modified ash worth scale (MAS)
The original ash worth scale by Bryan Ashworth was a five point numerical scale that graded spasticity from 0 to 4, with zero being no resistance and 4 being a limb rigid in flexion or extension. In 1987 when while performing a study to exam reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the ash worth scale by adding 1+ to scale to increase sensitivity. Since modified ash worth scale has been applied in clinical practice and research as measure/grade muscle spasticity

Full Information

First Posted
July 24, 2022
Last Updated
August 4, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05491863
Brief Title
Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy
Official Title
Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cerebral palsy is a permanent damage in early brain in fetus which leads to movement disorder. The most frequent reason of bodily incapacity is cerebral palsy in pediatric population. CP children have difficulty maintaining dynamic and static trunk stability, which leads to affect sitting, standing, reaching and walking. Hemiplegic Cerebral palsy patients are challenged by fine motor skills, like gripping or object handling, which are essential for activities of daily life.the purpose of the study was to evaluate the effects of trunk stability exercises on hand function in children with cerebral palsy.It was a randomized, controlled trial, conducted among hemiplegic cerebral palsy patients. Sample size was 26 by using Epitool software. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on three occasions: (i) baseline (ii) post-intervention and (iii) after 4 weeks follow to assess long term effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
trunk stability, hand function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
. 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
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conservative physiotherapy plan
Arm Type
Active Comparator
Arm Description
Postural and Proprioceptive facilitation,walking ,jumping and staircase activity
Arm Title
Trunk stability exercise plan
Arm Type
Experimental
Arm Description
Trunk stability exercises including proprioception,balance and stability.
Intervention Type
Other
Intervention Name(s)
conservative physiotherapy plan
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
trunk stability exercise plan
Intervention Description
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)
Primary Outcome Measure Information:
Title
Trunk Control Meaurment Scale
Description
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.
Time Frame
12 week
Title
ABILHAND-kids (Manual Ability Measure)
Description
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 .
Time Frame
12 week
Title
CHEQ (Children's hand-use experience's questionnaire)
Description
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 .
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
UE MAL
Description
It consists of both the AS and HW scales are used during all test administrations, except for the periodic administrations of MAL during treatment, when only the HW scale is used. In all administrations except those done during treatment, begin with AS scale and ask participants to rate all task using the AS scale first the participant than rates all tasks perform with the HW scale
Time Frame
12 weeks
Title
Manual ability classification system
Description
It's a 5 level ordinal classification system which describes the manual ability of children aged 4 to 18 years with cerebral palsy. When children holds objects in typical activities, MACS levels describe the collaborative use of both hands together in daily life activities .As a classification system the purpose of MACS is to discriminate meaningfully on child's manual ability to handle objects in daily living. It's not an outcome measure or diagnostic tool
Time Frame
12 weeks
Title
Modified ash worth scale (MAS)
Description
The original ash worth scale by Bryan Ashworth was a five point numerical scale that graded spasticity from 0 to 4, with zero being no resistance and 4 being a limb rigid in flexion or extension. In 1987 when while performing a study to exam reliability of manual tests of elbow flexor muscle spasticity, Bohannon and Smith modified the ash worth scale by adding 1+ to scale to increase sensitivity. Since modified ash worth scale has been applied in clinical practice and research as measure/grade muscle spasticity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Shafique, tDPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising sun institute for special children
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54792
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Trunk Stability Exercises on Hand Function in Children With Cerebral Palsy

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