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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05491863
Other study ID # REC/RCR & AHS/22/0710
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2021
Est. completion date May 25, 2022

Study information

Verified date August 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 25, 2022
Est. primary completion date February 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
conservative physiotherapy plan
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 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)

Locations

Country Name City State
Pakistan Rising sun institute for special children Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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 12 weeks
Secondary 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 12 weeks
Secondary 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 12 weeks
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