ClinicalTrials.gg
RecruitingNCT07248735Updated Nov 25, 2025

Effects of CIMT With and Without Robotic Gloves in Children With Hemiplegic CP

An interventional study of CIMT with robotic glove and CIMT with standard rehabilitation in Child Development Disorder, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Riphah International University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

Read the detailed description

Hemiplegic cerebral palsy (CP) often affects one side of the body, limiting functional abilities. Constraint-Induced Movement Therapy (CIMT) is a common intervention where the unaffected hand is restricted to encourage the use of the affected hand. Recently, the addition of robotic gloves has been proposed to improve outcomes, as they offer mechanical support and feedback to the affected hand. This study investigates the impact of CIMT, with and without robotic gloves, on hand dexterity and grip strength in children with hemiplegic CP, aiming to enhance motor skills and promote independence in daily activities. Conducted as a randomized controlled trial at DHQ Hospital, Mandi Bahauddin, the study involves two groups of children aged 6-12 with hemiplegic CP. One group of 17 children will receive CIMT alone with standard treatment, while the other 17 will receive CIMT combined with robotic glove assistance. The robotic glove device aids in flexion, extension, and individual finger movements, providing support for both isolated and coordinated finger actions. Each therapy session will last six hours and be held three to five days a week over four to eight weeks.

02

Conditions studied

  • Child Development Disorder

Keywords

  • CIMT, Robotic Gloves, Dexterity, Hemiplegic CP
03

In context

Developmental Disabilities

230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.

This study's planned enrollment of 34 is below the median of 60 across 150 interventional studies indexed under Developmental Disabilities.

Browse Developmental Disabilities studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 6-12 years with Hemiplegic CP.
  • Both Genders will be included.
  • Fulfilling the CIMT criteria i.e. Up to 20 Degree Wrist Extension, up to 10 Degree
  • Thumb Abduction and Up to 10 Degree Finger Extension.
  • GMFCS level of 1 and 2.
  • MAC Grade 2 and 3.
  • Ability to understand and follow simple instructions.

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairment or intellectual disability.
  • Presence of other neurological disorders such as epilepsy.
  • Children currently participating in other intensive physical therapy programs.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Group A

    Experimental group

    Other: CIMT with robotic glove

  • Active comparator
    Group B

    Control group

    Other: CIMT with standard rehabilitation

Interventions

  • OtherCIMT with robotic glove

    The Experimental group undergoes a comprehensive rehabilitation program, combining Constraint-Induced Movement Therapy (CIMT) with robotic glove therapy. The unaffected limb is restrained by the help of Slings, Simple glove, splint or plaster. Each session lasts 6 Hours, occurring 3-5 Days a weekly, over a period of 4-8 weeks. This intensive regimen aims to enhance hand function and mobility by constraining the unaffected hand while using the robotic glove to facilitate precise finger movements.

  • OtherCIMT with standard rehabilitation

    Controlled group receives CIMT with baseline rehabilitation. Only receives CIMT without Robotic Gloves. Additional assessments may be conducted after 3 or 6 months to measure long-term effects.

06

What researchers measure

Primary outcomes

  1. Grip Strength Test

    The grip strength test and pinch strength is used to assess function of the hand using dynamometer. Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength

    Time frame: 4-8 weeks

  2. Box and Block Test

    The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. The BBT is composed of a wooden box divided in two EFFECTS OF CIMT WITH AND WITHOUT ROBOTIC GLOVES IN CHILDREN WITH HEMIPLEGIC CP 11 compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds

    Time frame: 4-8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Osuagwu BAC, Timms S, Peachment R, Dowie S, Thrussell H, Cross S, Shirley R, Segura-Fragoso A, Taylor J. Home-based rehabilitation using a soft robotic hand glove device leads to improvement in hand function in people with chronic spinal cord injury:a pilot study. J Neuroeng Rehabil. 2020 Mar 5;17(1):40. doi: 10.1186/s12984-020-00660-y. PubMed 32138780 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jan 2026, 2 months after the start.

Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 2 months is below that.

Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 25, 2025
StartActual
Oct 29, 2025
Primary completionEst.
Jan 25, 2026
CompletionEst.
Jan 30, 2026
Last update
Nov 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07248735
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Oct 29, 2025
Primary completion
Jan 25, 2026 (estimated)
Completion
Jan 30, 2026 (estimated)
Last update
Nov 25, 2025

Study contacts

Imran Amjad, PhD
Contact
imran.amjad@riphah.edu.pk
9233224390125
Muhammad Asif Javed, MS-PT
Contact
a.javed@riphah.edu.pk
923224209422
Aftab Ansar Lodhi, MS-PT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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