NCT06933147

Brief Summary

This study explored two common rehabilitation strategies-Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)-to help stroke survivors improve movement and function in their weaker arm. Stroke can often lead to reduced mobility in one arm, which affects a person's independence and quality of life. This randomized clinical trial involved 64 patients between the ages of 40 to 60 who had experienced a stroke and were in the sub-acute phase of recovery. Participants were randomly assigned to one of two groups: one group received CIMT and the other received RT. The CIMT group had their unaffected arm restrained for 6 hours per day and completed 3 hours of supervised exercises using the affected arm. The RT group participated in structured strength training using weights to target shoulder, elbow, and wrist muscles. Both groups were treated five days a week for 12 weeks. Throughout the study, researchers assessed participants using three tools: the Action Research Arm Test (ARAT) for arm function, the Fugl-Meyer Assessment (FMA) for motor recovery, and the Stroke-Specific Quality of Life Scale (SS-QOL) for overall well-being. These assessments were conducted at baseline, week 4, week 8, and week 12.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 3, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

Action Research Arm TestConstraint-Induced Movement TherapyFugl-Meyer AssessmentQuality of LifeResistance TrainingStroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test (ARAT)

    The ARAT is a standardized test used to assess upper extremity motor function. It evaluates grasp, grip, pinch, and gross arm movement using 19 items scored on a 4-point scale. Scores range from 0 to 57, with higher scores indicating better function.

    Baseline, Week 4, Week 8, and Week 12

Secondary Outcomes (2)

  • Fugl-Meyer Assessment (FMA) - Upper Extremity Section

    Baseline, Week 4, Week 8, and Week 12

  • Stroke-Specific Quality of Life Scale (SS-QOL)

    Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

Constraint-Induced Movement Therapy (CIMT) Group

EXPERIMENTAL

Participants in this group received Constraint-Induced Movement Therapy (CIMT) for 12 weeks. The unaffected upper limb was constrained for 6 hours per day using a mitt, and patients completed 3-hour daily sessions of task-specific functional training with the affected limb, 5 days per week. Exercises included grasping, stretching, pushing, button pressing, and fine motor tasks designed to improve upper limb function and daily activity performance. A home exercise plan was also provided.

Behavioral: Constraint-Induced Movement Therapy (CIMT)

Resistance Training (RT) Group

EXPERIMENTAL

Participants in this group underwent Resistance Training (RT) focused on the affected upper extremity for 12 weeks. Exercises targeted shoulder, elbow, and wrist muscles using weight cuffs (½-1 kg) based on 1RM assessment. Each session included 3 sets of 8 reps for 4 different exercises, 5 days a week. The training started with 50% 1RM intensity for 4 weeks and progressed to 70% over the next 8 weeks. Sessions lasted 60 minutes and included rest intervals. A structured home exercise program was also provided.

Behavioral: Resistance Training (RT)

Interventions

This intervention involved constraining the unaffected upper limb for 6 hours per day and performing 3-hour intermittent daily sessions of functional task practice with the affected limb for 12 weeks, 5 days per week. Exercises included stretching, grasping, dexterity tasks, and functional activities like self-feeding and button pressing. The program used shaping techniques to increase task difficulty and improve motor recovery. A home exercise program was also prescribed for daily practice.

Constraint-Induced Movement Therapy (CIMT) Group

This intervention consisted of structured progressive resistance exercises targeting the affected upper limb muscles (shoulder, elbow, wrist) using weight cuffs (½-1 kg). Sessions were 60 minutes/day, 5 days/week, for 12 weeks. Intensity progressed from 50% to 70% of 1-repetition maximum (1RM) based on individual capacity. Exercises were performed in 3 sets of 8 repetitions for each muscle group, with 2-minute rest intervals. A home program included additional wrist and hand strengthening tasks.

Resistance Training (RT) Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient having age between 40-60 years
  • Both gender were included
  • Patient diagnosed with hemiparesis having grade 1 or 2 using Modified Ashworth Scale (MAS)
  • Participant able to sit independently for 60 min
  • Patients experiencing functional limitations in upper limb motor function

You may not qualify if:

  • Participants with severe aphasia, severe shoulder pain affecting therapy or any comorbid condition that could limit UE function, visual or hearing impairment
  • Uncontrolled pain or spasticity in the affected arm
  • History of shoulder instability or major orthopedic surgery in the affected arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (2)

  • Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.

    PMID: 30871480BACKGROUND
  • Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.

    PMID: 27447365BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement TherapyResistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 18, 2025

Study Start

October 15, 2024

Primary Completion

March 19, 2025

Study Completion

April 2, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations