NCT06548295

Brief Summary

"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 7, 2024

Last Update Submit

August 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Barthal index

    Barthel Index (BI) stands out as a widely utilized measure for assessing basic activities of daily living (ADL). Scores of 0-20 indicate "total" dependency. Scores of 21-60 indicate "severe" dependency. Scores of 61-90 indicate "moderate" dependency.

    12 Months

  • The use of FMA-UE

    measureing comprising 30 items for motor function and 3 items for reflex function, provides a comprehensive evaluation of motor abilities . In regards to UE feature, 33 elements evaluate motor function, six items assess sensitivity and proprioception, while the last 24 points rate joint pain and mobility. Every item of the assessment scale is marked on an ordinal level, from 0 to 2; the 0 value corresponds with the impossibility to perform a movement, and 2 represents the ability to perform a complete and adequate movement

    12 months

Study Arms (2)

modified constraint induced movement therapy (mCIMT)

EXPERIMENTAL
Behavioral: modified constraint induced movement therapy (mCIMT)

conservative treatment

EXPERIMENTAL
Combination Product: conservative treatment

Interventions

Restraint the involved extremity by using a mitten. Repetitive task practice i.e filling a glass, drinking a glass of water, and eating with a spoon , stacking cones and stacking blocks, grasping and releasing of an object, reaching forward and sideways, lifting and dropping of an object from the one end of table to the other end. The shaping exercises included cube stacking, card turning, throwing balls into a box, grasping/holding and placing objects of different sizes, and drawing and painting exercises. Intervention: 5 sessions per week for 50 minutes for 6 weeks

modified constraint induced movement therapy (mCIMT)
conservative treatmentCOMBINATION_PRODUCT

The conservative rehabilitation program consisted of upper-limb range of motion exercises, positioning, stretching, and strengthening exercises, Passive mobilization of the shoulder ,elbow , wrist and small joints of hand Stretching of the affected arm including biceps, triceps and muscles of forearm and hand. Strengthening exercises of upper arm and forearm muscles involved. Intervention: 5 sessions per week for six weeks and 50 mintues

conservative treatment

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be under the age of 40-75 years
  • Diagnosis: stroke

You may not qualify if:

  • patients suffering from motor dysfunction due to other diseases (e.g., cerebral palsy, traumatic brain injury, and Parkinson's disease
  • Balance problem
  • Rheumatic diseases
  • High spasticity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Little angles home aziz bhati shaheed road opposit junior aps

Sialkot, Pakistan

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 12, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 30, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations