NCT06690073

Brief Summary

  1. 1.To find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
  2. 2.To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among chronic hemiplegic subjects.
  3. 3.To find out the effectiveness of motor relearning program along with conventional physical therapy treatment over conventional physical therapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2024

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 Start

First participant enrolled

November 4, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 10, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

StrokeHemiplegiaFunctional mobilitymotor relearning program

Outcome Measures

Primary Outcomes (2)

  • Barthel Index (BI)

    The Barthel index, frequently used for stroke, gauges the level of help needed by an individual for ten mobility and daily living tasks. The total of all weighted individual item scores is converted into a single overall score, which ranges from 0 to 100. Consequently, "0" represents total independence from all ten activities. It takes 5 to 10 minutes to complete, has strong validity and reliability, and has minimal sensitivity for high-level functioning (Bhalerao et al., 2011).

    week 0 and week 6

  • Motor Assessment Scale (MAS)

    MAS is used to evaluate motor skills. MAS records eight functional activities: rolling in bed, sitting, sit to stand, walking, balancing in seated position, upper arm, hand, and wrist activities. The general tone of the body is noted in the ninth item. The scale for each item is 0 to 6. Hence, a score of 0 to 54 (normal function). According to WHO guidelines, MAS is supposed to be tested on the severity of disabilities. The MAS was highly dependable, with an average inter-rater reliability of .95 and an average test-retest reliability of 0.98 (Bhalerao et al., 2011).

    week 0 and week 6

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional Physical Therapy (CPT) was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group.

Other: Conventional Physical Therapy

Experimental

EXPERIMENTAL

the experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week. MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft

Other: Motor Relearning Program

Interventions

Total duration of the intervention is 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week. MRP of sitting and standing activities: The physical therapist will instruct the participant, who will be seated in an armrest-equipped chair, to keep their feet back and position their trunk forward.. The participant will then be guided to press down through the affected foot, stand up quickly, and move their hips forward. The therapist will suggest pressing down through the participant's knee along the leg while moving it forward through the affected foot. MRP of standing to sitting: The participant will stand while the physiotherapist assists with anterior shoulder movement and knee bending at the start of the transition. The therapist will then help maintain weight on the affected leg while sitting. The participant will progress by standing and sitting at different seat heights, stopping at various points in the ROM, and changing speed.

Also known as: Conventional Physical Therapy
Experimental

Conventional Physical Therapy (CPT) will be administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training will be given to the control group.

Control

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right or left-sided chronic hemiplegic subjects.
  • More than six months after the onset of stroke.
  • Age group between 45-65 years of both genders.
  • Scored minimally 24/30 on the Mini-Mental State Exam (MMSE).
  • Motor assessment scale of sitting to standing section.
  • Having normal visual perception.
  • Able to follow verbal commands.

You may not qualify if:

  • Less than six months after the onset of stroke.
  • Unable to follow visual and oral commands.
  • The age group is below 45 years and more than 65 years.
  • Unilateral neglect.
  • Cognitive impairments (MMSE scores less than 24/30), or language deficits.
  • Any other neurological disorders and recent surgeries.
  • Previous exposure to MRP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud Medical City

Riyadh, Riyadh Region, Saudi Arabia

RECRUITING

Related Publications (1)

  • Alfaleh KA, Shaik AR, Balasubramanian K, Alshehri MM, Sanjeevi RR, Esht V, Alsalem WO, Shahhar AM, Alothman SA. Effectiveness of motor relearning program in sit-to-stand transfer and activities of daily living among chronic stroke patients - a prospective, multicenter, randomized controlled trial. J Comp Eff Res. 2026 Jan;15(1):e250133. doi: 10.57264/cer-2025-0133. Epub 2025 Dec 9.

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohammed Mansour Al Shehri, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 10, 2024

First Posted

November 15, 2024

Study Start

November 4, 2024

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

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