NCT07060430

Brief Summary

This study is a randomised control trial and the purpose of this study is to determine comparision of Kaltenborn Mobilization and Mobilization with Movement (MWM) in wrist Hpomobility after Colle's fracture.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

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

September 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

May 28, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Range of Motion at wrist

    Range of Motion at wrist will be measured by goniometer

    1st measurement taken before starting session (Baseline measurement) 2nd or post measurement taken after end of sessions (after 3 weeks) (2 points measurement would be taken) 9 treatment sessions in 3 weeks is total time period.

  • Wrist Pain

    Measured by PRWE questionnaire. Patient-Rated Wrist Evaluation is a 15-item questionnaire help to assess wrist pain and disability during daily tasks The Pain Subscale consists of 5 items, ranging from 0 to 10. The total score ranges from 0 (no pain) to 50 (maximum pain).

    1st measurement taken after 3 or 4 sessions of treatment 2nd or last/post measurement taken at end of session (after 3 weeks) (2 points measurement would be taken).

  • Functional disability

    Measured by PRWE questionnaire. Patient-Rated Wrist Evaluation is a 15-item questionnaire help to assess wrist pain and disability during daily tasks. The Function Subscale includes 10 questions divided into two parts-6 questions assess specific activities, and 4 questions assess usual activities. The score for this subscale also ranges from 0 (no difficulty) to 50 (maximum difficulty).

    1st measurement taken after 3 or 4 sessions of treatment 2nd or last/post measurement taken at end of session (after 3 weeks) 2 points measurement would be taken)

Secondary Outcomes (1)

  • Grip Strength

    1st measurement taken before starting session (Baseline measurement) 2nd or post measurement taken after end of sessions (after 3 weeks) (2 points measurement would be taken) 9 treatment sessions in 3 weeks is total time period.

Study Arms (2)

Kaltenborn mobilization

EXPERIMENTAL

Group 1 will recieve heat therapy and then Kaltenborn mobilization. Supervise exercise protocol will be given Wrist, forearm and fingers ROM and isometric exercises. Introductory hand grip exercises Hand grip strengthening exercises

Procedure: Kaltenborn Mobilization

Mulligan mobilization with movement

ACTIVE COMPARATOR

Group 2 will receive heat therpy and then Mulligan Mobilization with Movement Supervise exercise protocol will be given Wrist, forearm and fingers ROM and isometric exercises. Introductory hand grip exercises Hand grip strengthening exercises

Procedure: Mulligan Mobilization with Movement

Interventions

All participants received a standardized treatment regimen first. This began with the application of a hot pack or infrared therapy for 10 to 15 minutes at the start of each session. then this group will receive Kaltenborn mobilizations with each mobilization technique performed for 10 repetitions, and each repetition maintained for 2 to 3 seconds. Mobilizations included palmar (volar) glide, dorsal glide, radial glide, and ulnar glide. In addition to wrist mobilizations, anterior and posterior glides were applied to the distal radioulnar joint.

Kaltenborn mobilization

All participants received a standardized treatment regimen first. This began with the application of a hot pack or infrared therapy for 10 to 15 minutes at the start of each session. then this group will receive Mulligan's Mobilization with Movement (MWM) technique, which involved 10 repetitions of each mobilization, with each repetition held for 2 to 3 seconds. First, a lateral glide or rotational movement of the carpal bones on the radius was applied, accompanied by the patient actively performing the intended wrist movement, such as flexion, extension, or deviation. Second, an ulnar-directed mobilization of the radius was provided simultaneously with active patient movement.

Mulligan mobilization with movement

Eligibility Criteria

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

You may qualify if:

  • Both male and female participants (40-70 years old) Participants who will have diagnosed Colle's fracture and treated conservatively by plaster cast fixation and should referred from department of orthopedic surgery Patients group with post Colle's fractures stiffness

You may not qualify if:

  • Patients having diagnosed Colle's fracture and treated with invasive procedure like K wiring, ORIF etc.
  • Patient with Neuromuscular injuries.(diagnosed)
  • Rheumatoid arthritis.
  • Patients with metacarpal fracture or compartment syndrome, non-union.(diagnosed)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Colles' Fracture

Interventions

Movement

Condition Hierarchy (Ancestors)

Fracture DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesRadius FracturesFractures, Bone

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 11, 2025

Study Start

September 15, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

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