NCT07629011

Brief Summary

This randomized controlled trial is to determine the effects of robotic hand training in improving upper limb motor function and coordination with and without mental imagery training in chronic stroke patients

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress31%
Apr 2026Nov 2026

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

April 2, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

Stroke rehabilitationMental imagery trainingTask oriented trainingupper limb rehabilitationmotor function

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment Upper Extremity (FMA-UE).

    Evaluate sensorimotor impairment after stroke, especially in the upper limb. 3 Sections, (A) UPPER EXTREMITY 1. Reflex Activity on paretic side (2 items) Bicep reflex Tricep reflex 2. Volitional movements within synergies pattern Flexion synergy ,Extensor synergy 3. Volitional movement mixing synergies 4. Volitional movement with little or no synergy (B) Wrist Stability at 15 dorsiflexion (DF) (Elbow at 90)Repeated (DF) (Elbow at 90) Stability at 15 dorsiflexion (DF) (Elbow at 0) Circumduction (C)Hand Mass Flexion ,Mass Extension GRASP Finger mass flexion /Finger mass extension Thumb adduction ,Opposition, Cylindrical grip ,Spherical grip Normal = Score 0-66 A UE /36 B Wrist /10 C Hand /14

    6 weeks

  • Action research arm test (ARAT)

    The ARAT is an observer-rated, performance-based assessment designed to measure upper extremity function and dexterity, especially after stroke or other cortical injuries. 4 Subscale * Grasp (6 items) * Grip (4 items) * Pinch (6 items) * Gross movement (3 items). Total score = 57

    6 weeks

  • Box and block Test (BBT)

    Measures gross manual dexterity and speed Equipment: Wooden box (≈ 53.7 × 25.4 × 8.5 cm) with a partition, plus 150-152 blocks (≈ 2.5 cm cubes) Primary score: Number of blocks successfully transferred in 60 seconds (per hand).Only blocks completely transferred count; dropped blocks are excluded

    6 weeks

Secondary Outcomes (1)

  • Modified ashworth scale (MAS)

    6 weeks

Study Arms (2)

Mental imagery training with Robotic hand training Group

EXPERIMENTAL
Other: Mental imagery training combined with Robotic hand training

Robotic hand training

ACTIVE COMPARATOR
Other: Robotic hand training

Interventions

Participants will receive combined training of robotic hand-assisted task practice and mental imagery training over 7 weeks, 3 sessions per week, totaling 20 sessions. Each session (\~60 minutes) conducted in a quiet room with the patient seated upright (hips, knees, ankles at 90°, forearms on table). Training involves real-life object handling tasks using three grip types: 1. Spherical grip (cricket ball - 109g, 75mm) 2. Tripod grip (woodblock - 74g, 50mm) 3. Tip pinch grip (small cube - 8g, 25mm) For each task (15 minutes), MIT duration will be 10 minutes 1. 2 repetitions - Watch task video (first-person view) 2. 5 repetitions - Imagine performing the task (eyes closed, paretic hand) 3. 3 repetitions - Perform the task with soft robotic hand assistance 4. The above sequence is repeated twice per task.

Mental imagery training with Robotic hand training Group

Each session included a 5-minute warm-up, followed by three 15-minute EMG-driven, robot-assisted task blocks and two 5-minute breaks. Robotic Hand Tasks include: Real-life object handling using three grip types: 1. Spherical grip - Cricket ball (109g, 75mm) 2. Tripod grip - Woodblock (74g, 50mm) 3. Tip pinch grip - Small cube (8g, 25mm) Muscle Monitoring: EMG signals recorded from flexor digitorum, extensor digitorum, biceps brachii, and triceps brachii. Maximum Voluntary Contraction assessed before each session; EMG activation threshold set at 3×SD above baseline. Training Activities will include: Grasping, lifting, holding, transporting, and releasing objects with robotic assistance and verbal guidance. Each 15-minute block included \~30-40 repetitions per task.

Robotic hand training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants clinically diagnosed with stroke in chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after stroke.
  • years of age.
  • Sufficient cognition to follow simple instructions and understand the content and purpose of study (MMSE score 28)
  • Able to sit up for at least 45 minutes.
  • Detectable residual signals from the affected side's Flexor digitorum (FD) and Extensor Digitorum (ED) muscles.
  • Modified Ashworth Scale (MAS) score of finger extensor less than or to 3
  • Ability to provide informed consent

You may not qualify if:

  • Patients with severe dysphasia with inadequate communication.
  • Any additional medical or psychological condition affecting their ability to comply with the study protocol.
  • History of other neurological disease or psychiatric disorders, including alcoholism and substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ayesha Umer, MS-NMPT*

    Riphah International Unversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arshad Nawaz Malik, PhD Rehab

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2026

First Posted

June 5, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations